550 - FDA Approved Phase 3 MDMA

Program Notes

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Lorenzo looks on as Jon Hanna delivers the very first Palenque Norte Lecture at the 2003 Burning Man Festival.

Date this lecture was recorded: September 1, 2017

Today we feature the 2017 Palenque Norte Lecture delivered by the founder of the Multidisciplinary Association of Psychedelic Studies, Rick Doblin. In this wide ranging talk, besides an update about the recent FDA approval for MAPS’ major Phase 3 study of MDMA, we are treated to the fascinating story of how Rick was able to convince his conservative family into supporting his decision to pursue the investigation of psychedelic medicines.

“What I intimated in my early LSD and mescaline sessions, they weren’t all beautiful and peaceful and, you know, unity with god. They more were like taking a very ridged intellectual person and helping me to start to feel, and helping me have emotions, and helping me to start to wrestle with some deeper emotions.” -Rick Doblin

MAPS.ORG
http://www.maps.org/

Transcript

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Greetings from cyberdelic space, this is Lorenzo and I’m your host here in the Psychedelic

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Salon.

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This is Lorenzo, and I’m your host here in the Psychedelic Salon.

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And today I’m going to play another of the 2017 Palenque Norte lectures,

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the ones that the good folks at Camp Soft Landing sponsored at the recent Burning Man Festival.

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And thanks to their good work and the dedication of Frank Nuncho, who recorded these talks for us, well, today we’re going to hear a recent update by Rick Doblin

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concerning the important breakthrough in MDMA research that’s just recently taken place.

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Now, if you’ve been with us here in the salon for a while, you already know that I’ve been aware of the work of Rick Doblin for a long time,

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before he even founded the MAPS organization, in fact.

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When I first learned of his amazing efforts to promote the medical benefits of MDMA,

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well, he was a real hero to me and my friends because, well,

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he was right up there on the front lines of political action

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while we were still deep in the underground selling MDMA to large numbers of people in Dallas, Texas.

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So when a potential customer would ask us about why we thought they should give MDMA a try,

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well, we’d give them copies of stories about Rick that were published in some of the mainstream publications.

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Thus, well, at least in our own minds, giving some legitimacy to what we were doing in the underground.

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So, while we were dodging the authorities, Rick was right up there in their

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faces giving them the facts about the potential of using MDMA as medicine. Now, after more than

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30 years of hard work, Rick has been able to get the U.S. government, the leading bad guys in the

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war on drugs, to finally admit that, yes, MDMA might just be what they so

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desperately need to fight the ever-growing numbers of our fellow citizens who are suffering

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from post-traumatic stress disorder.

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And that, my fellow Saloners, is an accomplishment of monumental proportions.

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Granted, it has taken the combined efforts of MAPS’s volunteers and staff, their donors, both large and small, and the continuing support of all of us.

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But without Rick Doblin, I personally don’t think that we would be anywhere nearly as close as we now are to seeing therapists trained and licensed to use MDMA in their practices.

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and licensed to use MDMA in their practices.

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As we say in the Navy, when someone exceeds all expectations,

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well done, Rick, well done.

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And now let’s join some of our fellow psychonauts in the big tent at Camp Soft Landing on the last Friday night in August, the night before

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the burn, where Rick Doblin is delivering the last Planque

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Norte lecture of the 2017

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Burning Man Festival.

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Presenting phase three trials of MDMA for PTSD research.

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Welcome.

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Thank you very much.

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Well, thank you

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all at Planque Norte for

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organizing this. And I’d

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like to also

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thank the people who are running the tea house,

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Soft Landing Tea House.

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I’m proud

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to say that I saw the sunrise

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yesterday.

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I was super tired last night. I was here visiting with John Gilmore,

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and I said, I need a nap, so I just went over to the tea house

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and slept until about 3 in the morning and then checked out the temple.

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How many people have heard me talk before?

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Okay, a little bit less than half could.

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Because what I’m going to do today is to talk really briefly about the why.

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Why it’s important that our culture integrate psychedelics.

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And I think a lot of us already have some good ideas about that.

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So that part will be pretty brief about the why.

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And then I’m going to talk about the strategy and how we’ve tried to move forward with medicalizing psychedelics.

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And then I’m going to give you a sense of where we’re at right now and what is it looking forward

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into the future, and then what are the challenges, the regulatory issues that we still have to

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address with FDA and DEA as we roll it out. And I’ll give you kind of a grand perspective of how I think that psychedelics will be legal in 2035 for any use at all.

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And I think we’ll have medicalization of MDMA in 2021.

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And we’ll actually be able to open psychedelic clinics in the summer of 2019.

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open psychedelic clinics in the summer of 2019.

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So I’m going to explain how all this is possible and how all it comes about.

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But I’d also like to encourage you to ask questions at any point.

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So instead of me talking and, you know, I will come to an end at some point, and then we can have more dialogue.

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But I’d like to encourage you to ask questions at any point.

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So whenever something is coming up, just raise raise your hand and we can discuss it then so I think it’s sometimes

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better to address the questions when they come up and then it’ll be more relevant answers and

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then then we can have kind of a group dialogue I just am curious if if you’re willing to say

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if either you or a friend have benefited therapeutically from psychedelics,

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if you could just raise your hand. Okay. It’s something that has been used for thousands of

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years. So the why part of why we need to integrate psychedelics into our culture was something that I came to understand in 1972 when I was 18

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after taking a bunch of LSD and mescaline.

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I was really lucky that somebody came by my college

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with half a pound of mescaline.

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So I proceeded to buy all of it,

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and friends and I distributed it.

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And so it’s really a remarkable – it’s one of the most important psychedelics that’s not being researched right now.

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So the why that came to me then was looking at being a draft resistor for Vietnam,

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looking at our culture sort of embarking on this or continuing on this war

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that was counterproductive and senseless in a lot of ways,

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prior to that having been very much traumatized by the Cuban Missile Crisis

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when I was a little boy and just this whole idea of the world potentially exploding

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and us killing ourselves.

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And even before that, as a very young boy,

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was being raised Jewish and being taught about the Holocaust.

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So I think that in some ways I had this secondary trauma,

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but I was able to negotiate it from within a very loving family,

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and I had all the benefits that you could imagine

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to think about being empowered

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to change the world. So I was first off white, American, and we were the, just won World

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War II, and so we were the most powerful country in the world. So I kind of grew up believing

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American exceptionalism. I had no real discrimination that I experienced. I did get a lot of the Jews’ chosen people kind of thing, so that was good.

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And I was the firstborn male child.

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So I had every possible advantage, and also from a family that had come over as refugees in the 1880s

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from Russia and Poland on one branch and the other from Poland in the 1920s.

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And they had made themselves successful, the American dream,

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and they were willing to support me in whatever I wanted to do, which was really important.

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And so I kind of grew up realizing that my family would help me try to find what I wanted to do.

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And to their surprise and not complete pleasure,

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when I was 17 at college, I started doing LSD.

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I was the model child in high school.

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I never did anything wrong.

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I never got in trouble.

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I had a very boring high school life.

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And I sort of fulfilled my parents’ dreams.

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And then I went off to college, and within a couple months,

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I was clear that I needed to drop out and that I wanted to study LSD

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and that I wanted my parents to pay for it.

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And so my father was like, well, this is a terrible mistake,

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but you’re such a stubborn guy that if I don’t help you,

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you’ll go ahead and you’ll do it, and then you’ll realize it’s a mistake,

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but you won’t admit it because you want to see that you were right and I was wrong,

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and you’ll keep at it a long time.

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But if I help you, you’ll realize it was a mistake sooner.

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time, but if I help you, you’ll realize it was a mistake sooner. And then he was programmed by my grandparents from the age of four. He knew he had to be a doctor. He was a single child of immigrants.

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They were poor. He had to be a Jewish doctor. So he wanted to do the opposite with us. So he said,

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I have a shred of doubt. Maybe you know what you need to do. Maybe we don’t have it programmed.

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shred of doubt, maybe you know what you need to do. Maybe we don’t have it programmed. And so he said, yes, they would support me to go off at age 18 to study with Stan Groff and drop out of college

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and be a bad example for my two younger brothers and sister. And I felt that it was that sort of

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loving support that helped me to realize that, I mean, John can tell you that the technological advancements are miraculous.

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I mean, we’re making magic real in all sorts of different ways.

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And the ability, I think, for us to use the mind, to use rationality,

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to use our technology to solve the resource problems, to have enough food, to have enough shelter,

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to have enough water for the people in the planet, I think we can do that.

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I think we can technologically figure out ways to deal with global warming.

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We can technologically, using the brilliance of the human mind,

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come up with solutions to pretty much all of our problems.

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But what’s blocking that is the emotional, spiritual underdevelopment

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compared to our intellectual, cognitive abilities.

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And it’s those irrational passions and hatreds and fears and projections

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that are really what’s threatening our ability as a species

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and as a planet to move forward.

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And what I intimated in my early LSD and mescaline sessions,

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they weren’t all beautiful and peaceful and unity with God.

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They were more like taking a very rigid intellectual person

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and helping me to start to feel and helping me have emotions

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and helping me just starting to wrestle with some deeper questions.

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But it was problematic.

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And so I was so lucky to go to the guidance counselor at my college

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and say, help me with my tripping.

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And this fellow said, yes.

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Keep in mind, this is 1972.

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And so he handed me a book by Stan Groff

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that was called Realms of the Human Unconscious.

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And it was about the research with psychedelics,

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about their mapping of the Human Unconscious. And it was about the research with psychedelics,

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about their mapping of the unconscious,

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their very much focus on spirituality, the spiritual experience.

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And it was science.

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And it had political implications from the kind of experiences people had.

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And at the same time, it was about therapy. It was like the reality check

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of can we use these drugs to actually help people get better. So it wasn’t abstract philosophy or

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abstract for religion. It was kind of all of that focused on a therapeutic project. And so I felt

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that’s it. And I realized that the psychedelics were all shut down, and I would work to try to bring them back.

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So that was my mission at age 18.

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And the core sort of theory of social change that I came to was that these ideas, how we define ourselves,

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the way that we think of us in our race, our religion, our culture, our gender, our gender orientation, our socioeconomic status,

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all of those things are important.

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We’re tribal, we’re group animals,

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and we have all these different ways that we become part of groups,

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and that’s where we get our identities.

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But deeper than that is the web of life.

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Deeper than that is part of the human family, part of the web of life.

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And if you can experience that and know that,

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then you’re not going to hate people so much that are different from you.

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You’re not going to be so much scared.

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If you know your commonality under that, under all the differences,

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then we appreciate differences.

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We won’t be so much fearful.

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And then we’ll work on common strategies.

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So that was the concept.

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And I had that reaffirmed for me in 1983

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when I read a book by the Assistant Secretary General of the United Nations, Robert Mueller.

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It was New Genesis, Building a Global Spirituality.

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And so what his view was that at the UN,

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working on mediating conflicts between nations,

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that a lot of the conflicts were religious-based

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and that what we needed to go further

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was to have an understanding

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that all the different religions

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are using different cultural symbols,

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different words, different processes,

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but they’re all talking about the same thing.

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And that his fundamental thesis was that mysticism is the antidote to fundamentalism.

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That this sense of commonality, this unity that you can experience has profound political

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implications. And there’s actually been recent studies at the Imperial College in London looking at people that are getting psilocybin in research and are showing that

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their attitudes towards nature are changing afterwards. They’re becoming more politically

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progressive. So it’s sort of the intimations of things that we felt during the 60s that people

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were talking about how psychedelics can be an engine of the

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anti-Vietnam War movement and the engine of environmental movement, a lot of things.

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So we have both experimental confirmation from some recent studies, and Robert Mueller was saying

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from the UN perspective that this is what he felt was necessary, but he didn’t really

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talk about psychedelics. So I wrote him a letter and said, will you help with psychedelics?

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And to my surprise, he wrote me back.

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So I was just a college undergraduate, and he gave a list of mystics of different religions

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for me to contact.

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And of course, I read between the lines, and I heard him say, send them MDMA.

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And so I did.

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And so Roman Catholic monks, Jewish rabbis, Zen meditators,

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people around the world who would then take MDMA in monasteries sometimes for meditation

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and Zen meditation centers and other contexts

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and report back to Robert Mueller that it seemed to work.

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And then he and I kept in contact. So this was really the why. I think that fundamentally

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psychedelics are a tool. They’re not a unique tool. People can get to these states of mind

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in other ways. They’re not essential. And I think that’s one of the mistakes of the 60s was for

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people to say, I’ve tripped, I know stuff that nobody else knows,

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and they can only know it in my way through taking these drugs. So I think it’s very important to

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affirm that there are multiple ways to these experiences, but that for many of us and for

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thousands of years in human history, psychedelics have been a catalyst for it.

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And so in the interest of effectiveness and efficiency,

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in the sense of how the crises we are require more rapid response,

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if we can manage that, that psychedelics integrated into culture will eventually give people the opportunity to have these kind of

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unitive mystical experiences, and that will change their attitudes and build a

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more successful and healthy world.

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And in addition, the therapeutic use of psychedelics, particularly MDMA for

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PTSD, we can be breaking multigenerational cycles of trauma.

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we can be breaking multigenerational cycles of trauma.

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And what we see and now know through epigenetics is that it’s possible in one generation for fears and anxieties

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of the mother to be passed on to the child.

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And so we know that it takes longer for genetic mutations to take place,

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but epigenetics is about which genes are turned on or off.

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And that you can affect in one generation, in one lifetime. Sometimes in one psychedelic experience

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you can, or one therapeutic experience, you can make those changes. So I think for us to break

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these cycles of multi-generational trauma, people who have hated each other for, you know, thousands

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or more years, and also for building this sense of we’re all in it together,

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I think it’s essential that we integrate psychedelics into our culture.

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And that was a motivating force for me at age 18.

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And now that I’m 63, I’m so happy it still makes sense.

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And not only does it make sense, but it makes sense even more.

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And I’ve seen so much how, over time, it just really feels right.

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And I’ve seen a lot of people who’ve had experience.

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Like, I’ll just share that the person that I go to sit with when I have my own LSD experiences, my own therapist, his father was a Nazi.

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Nazi. And so one generation down, you know, the son of a Nazi and the son of a Jew whose relatives were distant relatives killed in the Holocaust are like super tight. So I think

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that that for me is kind of a symbol of how much we can overcome these kind of divisions

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and things by having these deeper experiences

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and not projecting outward all the time, not scapegoating.

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So I think it’s absolutely essential.

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And it felt like if you can change consciousness, that will change everything else.

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You know, that people’s attitudes towards politics, towards the other,

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towards compassion will be changed.

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And so I felt there was a certain kind of high leverage value

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in going on integrating psychedelics.

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That’s why.

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All right, so now is the how.

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There’s multiple strategies.

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One strategy, because we’ve talked,

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I’ve just talked about the mystical experience.

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We’ve talked about thousands of years of psychedelics being used in mostly religious context,

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one approach is religious freedom.

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And what we see is that, sort of in this brief sweep of history,

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that the foundations of Western thought were the Greeks,

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and they had the longest-running mystery ceremony, 2,000 years, the Eleusinian Mysteries,

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wiped out in 396 by the Catholic Church that wanted to be the intermediary between spirituality.

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And so ever since then, really, we’ve not had much in the way of, and they saw the use of mushrooms, and they saw the use of peyote.

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Those were the big enemies, and they criminalized that.

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They killed and tortured a bunch of the shamans,

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and they tried to wipe that out because that was a competing source of power,

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and they came in with their new religion on top of Christianity.

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And really it was up until the 1890s where mescaline was first synthesized from peyote,

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and William James, who was at Harvard,

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started experimenting with nitrous oxide,

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the father of modern psychology,

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that psychedelics began to be woven back into Western culture,

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and there was a fair amount of research in the 30s and 20s

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with mescaline.

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It’s been said, I’ve tried

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to track it down, I haven’t been able to find the final

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reference, but it’s been said that the

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person who was in charge of the

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design of Fantasia for Disney

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had experiences with

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mescaline prior to that.

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So I’m not sure if that’s true, but it could be.

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But what we then see is, starting in the 50s,

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is really this expansion of the use of psychedelics

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and their both therapeutic role, their role in spirituality,

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and also their military use.

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And that sort of, you know,

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Ken Kesey first got LSD in a CIA experiment

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and then brought it out.

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And so we get this big, rapid evolution

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of an enormous amount of interest in the scientific community,

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thousands and thousands of studies,

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about 30,000, 40,000

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patients in studies, but it leaks out into the culture. Psychedelics be used by the anti-war

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movement, and then we get a backlash, and things are basically wiped out. And so the medical use

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then was a difficult route as well, and religious freedom is very limited. So what we have managed to get back in the U.S.

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is the Native American church

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has the religious freedom to use peyote.

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But the federal government,

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to try to block that from spreading,

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said that you had to have 25% Indian blood or more

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to be part of these ceremonies.

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So it’s the first racial division,

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racial requirement for religion.

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Completely nonsensical.

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A lot of states will let people participate in peyote

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no matter what their background is.

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But that is about half a million members

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of the Native American church

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can legally use peyote in the U.S.

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And then we also have the recent Supreme Court case

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with the uniao de vegetal, the use of ayahuasca.

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And they’re a branch of a Brazilian church, and they won freedom of religion.

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So ayahuasca in this religious context can be used.

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There’s the Santo Daime, which is another church.

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They went up to the Ninth Circuit.

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They won their case.

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So we have two ayahuasca churches.

00:23:01 ►

But there’s a concern about formalizing that as it grows

00:23:06 ►

because there’s a question if really why should we have to belong to religions that are older and established?

00:23:14 ►

We should be able to start our own.

00:23:16 ►

What’s the difference?

00:23:16 ►

We shouldn’t even have to have a group.

00:23:18 ►

We should be able to have our own individual spirituality.

00:23:20 ►

So there’s going to be legal limits on how well religious freedom will be expanded.

00:23:27 ►

And for those of you that are aware of the use of ayahuasca and the way that it’s spreading in the

00:23:31 ►

U.S., much of that use is illegal because it’s not formally in those religious settings. But at the

00:23:37 ►

same time, it’s sort of legal. There are certain kind of prayers, certain things. And so the DEA has basically

00:23:45 ►

not gone after the use of ayahuasca, even outside of these religious settings. And that

00:23:51 ►

is creating a really good opportunity for all sorts of people to be learning about the

00:23:56 ►

potential of psychedelics. So the religious freedom in a formal way is not going to expand

00:24:01 ►

much further, I don’t think. But the way in which it’s protecting sort of quasi-legal use is really remarkable.

00:24:10 ►

But I don’t think in a formal way it’s going to go.

00:24:12 ►

And I think the legalization effort is ultimately what we need

00:24:17 ►

because we all should have our own access to tools to change consciousness.

00:24:22 ►

And it shouldn’t be medicalized.

00:24:24 ►

It shouldn’t require, Cole, who’s a doctor doctor here working on our MDMA projects and caffeine projects.

00:24:29 ►

It shouldn’t require a prescription from Cole.

00:24:34 ►

Although when you get a prescription from Cole, then it should be covered by insurance.

00:24:41 ►

And it should be part of our mainstream medicine.

00:24:43 ►

But we should have all this individual freedom.

00:24:45 ►

And the question is, how do we get there?

00:24:48 ►

How do we get to a place where loads of people can have these experiences,

00:24:52 ►

can have this deeper knowledge, we can build a more healthy population?

00:24:56 ►

And I think the most strategic route is medicalization.

00:25:00 ►

And what we see from medical marijuana is that there were struggles during the 60s, 70s, a recognition of the beneficial uses of marijuana widespread.

00:25:16 ►

And it felt like the move towards legalization was sort of moving forward in the 70s.

00:25:24 ►

And Jimmy Carter was elected in 76

00:25:26 ►

on the platform of decriminalizing marijuana.

00:25:30 ►

But then there was a backlash

00:25:31 ►

by the rise of the parents’ movements.

00:25:35 ►

And suddenly there’s no talk anymore

00:25:38 ►

about marijuana legalization.

00:25:39 ►

And I remember discussions among people at Normal

00:25:42 ►

about debating which year marijuana would be legal.

00:25:48 ►

And some people saying, oh, you know, you’re saying five years, it’s going to be way sooner.

00:25:51 ►

So there was a lot of people that were hoping and thinking and misjudging the culture to the extent that we were caught unawares by this backlash.

00:26:02 ►

And that sort of blocked anything from expanding for several decades.

00:26:07 ►

And it wasn’t until 1996 that California and Arizona passed medical marijuana.

00:26:14 ►

And the attitudes towards legalization of the American voters,

00:26:18 ►

there’s been a Gallup poll, summary of Gallup polls since 1970 to just two years ago.

00:26:25 ►

And in 1970, it was 12% were in favor of legalization of marijuana.

00:26:29 ►

It rose to around 20% in the 70s.

00:26:32 ►

Then we get this backlash, and then it sort of stays the same for about 20 years.

00:26:36 ►

And starting in 1998 or so, attitudes towards legalization increased,

00:26:41 ►

and a few years ago, it crossed the 50 percent mark of 50 percent american voters but

00:26:45 ►

if you track the growth of support for legalization with the growth of the medical

00:26:53 ►

marijuana movement they’re pretty similar so the theory is that medicalization will lead to

00:27:00 ►

legalization and i think we’ve seen that with marijuana. But it takes decades. It

00:27:08 ►

takes a long time for that to happen. But I think that in our culture, using science, using medicine,

00:27:15 ►

trying to work through the FDA and focusing on illnesses that people have compassion for,

00:27:22 ►

that we can medicalize psychedelics. And so that’s the fundamental for that weaken medicalized psychedelics.

00:27:32 ►

And so that’s the fundamental strategy that I think is demonstrated to have been successful. Well, some of the polling has been done for why are people voting for marijuana

00:27:37 ►

and for marijuana legalization.

00:27:40 ►

And one of the findings was that if you knew a medical marijuana patient, that that was a powerful determiner of who was in support of legalization.

00:27:50 ►

So there’s so much misinformation people have gotten.

00:27:53 ►

But if you know somebody directly that has benefited, then that is your solid data point that you know for sure.

00:28:01 ►

So medicalization, I think, is the strategy that I’ve decided to adopt.

00:28:06 ►

And so in 82, I learned about MDMA.

00:28:10 ►

It was an underground drug, but it was also starting to be sold as ecstasy.

00:28:14 ►

So it was clear that the underground therapeutic use of MDMA was doomed

00:28:18 ►

and that the above-ground use of ecstasy was going to be the cause.

00:28:22 ►

But there was this interim period where it was legal,

00:28:25 ►

and we could prepare in different ways to educate different people

00:28:30 ►

and prepare our lawsuit against the DEA when they would inevitably move against MDMA.

00:28:36 ►

And so in the summer of 1984, DEA tried to criminalize MDMA.

00:28:40 ►

And there’s a 30-day period of comment.

00:28:43 ►

I went to D.C., filed some papers for this hearing,

00:28:46 ►

and we had a DEA administrative law judge hearing, which we won.

00:28:50 ►

The judge said MDMA should be Schedule III, available to medicine.

00:28:54 ►

But the head of the DEA rejected the recommendation.

00:29:00 ►

And so it was clear we couldn’t force them further.

00:29:03 ►

We sued them further in the appeals court.

00:29:05 ►

We won a couple times.

00:29:06 ►

Eventually we lost.

00:29:07 ►

So in 86, I started MAPS as a nonprofit pharmaceutical company,

00:29:11 ►

focused primarily on MDMA, but also other psychedelics and marijuana.

00:29:17 ►

And at the same time, I’m still training myself to become a psychedelic therapist

00:29:20 ►

and to one day be a legal psychedelic therapist.

00:29:28 ►

So it took us six years from 86 to 92 to get the first protocol approved by the FDA.

00:29:35 ►

They rejected five protocols before then, and it wasn’t so much that our sixth protocol

00:29:40 ►

was way better than the others.

00:29:42 ►

What happened was that the people at the FDA that regulated psychedelics switched, and a new group took over. And this new group decided that

00:29:52 ►

science over politics, and they would permit psychedelics and marijuana research to start.

00:29:58 ►

What had also happened is that I had tried to get into a clinical psych PhD program to learn about how to do psychotherapy outcome research with MDMA.

00:30:07 ►

Nobody would let me in.

00:30:08 ►

This is the late 1980s.

00:30:12 ►

And so I was blocked.

00:30:13 ►

I’d been since 72 to 88.

00:30:15 ►

I’d been thinking this is what I want to do, and now I can’t do it.

00:30:18 ►

So I decided to smoke some pot and think it over.

00:30:24 ►

And it’s a really good technique that many of us know

00:30:28 ►

when you’re in a box to try to question your assumptions.

00:30:32 ►

So I was under the influence of pot.

00:30:33 ►

I was like, I want to do this.

00:30:36 ►

I want too much too soon.

00:30:38 ►

The science is being blocked by the politics.

00:30:40 ►

Maybe I should switch and study the politics.

00:30:42 ►

So I decided, where am I going to study the politics?

00:30:45 ►

Harvard, Kennedy School of Government.

00:30:47 ►

I knew of a professor there.

00:30:49 ►

So eventually I managed to talk to him.

00:30:51 ►

I managed to get in.

00:30:52 ►

So I have this master’s and Ph.D. from the Kennedy School of Government

00:30:55 ►

with a focus on the regulation of the medical use of psychedelics.

00:31:00 ►

And while I was there for my master’s,

00:31:02 ►

I got what’s called a presidential management fellowship

00:31:05 ►

for people who want a career in the federal government.

00:31:08 ►

I kind of managed to use the credibility of the Kennedy School

00:31:11 ►

and get into this program,

00:31:12 ►

and then I tried to get a job at the FDA.

00:31:16 ►

And you can see how I’m dressed now,

00:31:22 ►

which is how I like to be dressed,

00:31:24 ►

but I was willing to give up drugs, wear a suit, and go into work at the FDA.

00:31:29 ►

And I almost got hired.

00:31:30 ►

I came super close to getting hired.

00:31:33 ►

But at the last minute, the DEA said that they would refuse to work with me.

00:31:37 ►

And I was, of course, trying to work with the FDA branch that works with Schedule I drugs.

00:31:42 ►

So in the end, I didn’t get the job.

00:31:44 ►

branch that works with Schedule I drugs. So in the end, I didn’t get the job, but the FDA people said they would help out informally and give us advice on how to bring projects to them.

00:31:52 ►

And they also approved our first study in 1992, which was a dose response phase one safety study

00:31:58 ►

with MDMA. And so that took us through much of the 90s. And then in 2000, I started working with

00:32:07 ►

Michael Midhofer, who was a psychiatrist trained by Stan Grof in the holotropic breath work.

00:32:13 ►

And he came to me in 2000 at the first ayahuasca conference that was in the United States,

00:32:21 ►

organized by Ralph Metzner in San Francisco. And Michael said, I’m a member of MAPS.

00:32:26 ►

I didn’t know him.

00:32:27 ►

He said, I’ve been trained with Stan Grof, as I had been.

00:32:29 ►

And he said, I would like to work with you on setting up an offshore clinic somewhere

00:32:33 ►

where we can treat people with psychedelics.

00:32:36 ►

So it took me about 10 seconds to say I’m absolutely not interested in that,

00:32:40 ►

that we can’t run to the periphery.

00:32:42 ►

In the era of global warming, and the era of nuclear weapons,

00:32:46 ►

in the era of globalization, there’s no safe place.

00:32:49 ►

There’s nowhere you can run.

00:32:51 ►

You’ve got to go to the heart of the system and change it from the inside out.

00:32:55 ►

So I said, let’s forget about this offshore clinic,

00:33:00 ►

and let’s go to the FDA and try to make change from there, and I think it can be done.

00:33:03 ►

offshore clinic and let’s go to the FDA and try to make change from there and I think it can be done. So it took us four years from 2000 to 2004 to get permission for the first

00:33:09 ►

MDMA study, which was mostly women survivors of childhood sexual abuse who were treatment

00:33:16 ►

resistant, had failed on both psychotherapy and pharmacotherapy, had PTSD an average of

00:33:22 ►

17 years or more,

00:33:28 ►

and were the hardest cases in many ways.

00:33:29 ►

But that’s who we started with.

00:33:31 ►

And while we were doing that study,

00:33:34 ►

because I was sort of aware of the potential for backlash,

00:33:37 ►

we started thinking of an international strategy.

00:33:41 ►

So we started research in Switzerland with MDMA,

00:33:43 ►

also in Israel, also in Canada.

00:33:50 ►

And so from 2004, where we started with these women survivors of childhood sexual abuse,

00:33:56 ►

then we started seeing more and more people coming back from Iraq and Afghanistan with PTSD.

00:34:02 ►

And so the question was, does MDMA work regardless of the cause of PTSD? Will it work in war-related PTSD as well as

00:34:05 ►

complex PTSD or childhood sexual abuse? And so we started a study that was with veterans,

00:34:13 ►

but for political reasons, we decided just to put in the title, it’s for veterans, firefighters,

00:34:19 ►

and police officers. We didn’t think we’d get any firefighters or police officers, but we just

00:34:25 ►

wanted to say, you know, those oppressors that we think of out there, this is for you too.

00:34:31 ►

And the way it turned out, and I’ve gotten a lot more compassionate for the police, is actually we

00:34:36 ►

did have one police officer volunteer for the study who had work-related PTSD. And we had several firefighters, one of whom had PTSD from 9-11.

00:34:47 ►

So what we were able to show in that study is that unlike Zoloft and Paxil,

00:34:53 ►

which are the only drugs approved by the FDA for PTSD,

00:34:57 ►

that tend to work more in women and not in men,

00:35:00 ►

and didn’t work whenever they have used it for combat,

00:35:03 ►

that MDMA worked for war-related PTSD,

00:35:06 ►

and MDMA worked for complex PTSD, and MDMA worked for PTSD from accidents. And so from starting in

00:35:14 ►

2000 to 2016, we completed a whole series of phase two pilot studies, the purpose of which is to

00:35:22 ►

figure out how to design phase three. And phase three

00:35:25 ►

are the pivotal studies that are required to make a drug into a medicine. So on November 29, 2016,

00:35:32 ►

we went before the FDA for what’s called an end of phase two meeting.

00:35:38 ►

And we had incredible, we treated 107 people, and we also had developed new relationships with two groups of people that were crucial to our negotiations.

00:35:52 ►

As I said, we started this in 1986, and it was 30 years before the end of Phase II meeting.

00:36:00 ►

And during that time, some of the key people with FDA that we had been working with had retired.

00:36:06 ►

And so through a chance meeting that I had with John with the daughter of one of the people from FDA who was seeking a job at the electronic frontier, we were able to get in touch with her father and others. So we have several senior FDA officials who worked at the Division of Psychiatry Products who are now consulting with us to help us work with FDA. And they’ve trained

00:36:30 ►

the people that are now in charge, too, of the Division of Psychiatry Products. And then a

00:36:35 ►

Burning Man connection that was around 2003 was what I call the refugees from big pharma.

00:36:43 ►

So a woman came to me, Amy Emerson, and she said she worked for Novartis.

00:36:48 ►

She wanted to help world’s largest pharmaceutical companies, one of them,

00:36:52 ►

and she wanted to help out.

00:36:54 ►

And she said, when you’re ready, let me know.

00:36:57 ►

And so a few years later, we got ready.

00:36:59 ►

And so now our core clinical team is a group of people,

00:37:02 ►

many of whom worked at Novartis, who are now working for

00:37:06 ►

MAPS. So we have the wisdom of the FDA regulators, the expertise and wisdom of Big Pharma, and the

00:37:12 ►

beauty of the people that we have from Novartis is that Novartis is the company that gobbled up

00:37:18 ►

Sandoz, and Sandoz is the company that Albert Hoffman worked for when he invented LSD and when he first synthesized psilocybin.

00:37:28 ►

So we have kind of the pharmaceutical psychedelic wisdom.

00:37:31 ►

And so all of these, and the other thing that we have going for us is, as you can tell, out in the wider culture,

00:37:38 ►

there has been this incredible recognition of the rate of suicides of veterans, the lack of available treatments, that the

00:37:46 ►

psychotherapies work in some people, but they leave a large number untreated. Yeah.

00:37:52 ►

I’m sorry, I may have missed it while I was walking up here.

00:37:55 ►

The part where we’re going to sort of bypass big pharma, is that where you were going with what

00:38:02 ►

you were just talking about? No, not really.

00:38:07 ►

What I’m basically saying is we have to become big pharma.

00:38:11 ►

So I’m saying we need to play the game.

00:38:15 ►

I think working with the system, working with the FDA.

00:38:19 ►

So MAPS is a nonprofit pharmaceutical company,

00:38:25 ►

and we are negotiating with FDA about the right to market MDMA as a prescription medicine.

00:38:31 ►

The difference is that we’re not out to maximize profits.

00:38:33 ►

We’re out to maximize social benefit.

00:38:36 ►

And so we’re not trying.

00:38:40 ►

There’s no, for all the people that work with us, we don’t have nondisclosure agreements. We don’t have any kind of confidentiality.

00:38:43 ►

There’s no secrets they have to protect. So

00:38:46 ►

in many ways, it’s the opposite of big pharma, but it is playing by the same rules and trying

00:38:52 ►

to work within the system that big pharma works within. So I think that’s an important

00:38:58 ►

distinction. The other way to say it, too, is that once MAPS makes MDMA into a medicine, then what we want to do is

00:39:07 ►

sell it as a medicine. It would be MAPS. And we also want to sell it for a bit more than it costs

00:39:13 ►

us so that we can, instead of constantly going to donors and saying, give us money, we’re a rare

00:39:18 ►

nonprofit in that we’re talking about having a product at the end. And there’s a program that the FDA has that was ironically

00:39:26 ►

developed by, signed into law by Reagan, so that if you’re working with a drug that is

00:39:33 ►

off patent, MDMA was invented in 1912 by Merck. And they did nothing with it. And their patent

00:39:41 ►

started, was getting close to being expired. And in 1927, Merck did a bunch of animal studies

00:39:46 ►

and they found nothing of interest and they just let it go.

00:39:50 ►

So there is no patent protection.

00:39:52 ►

There’s no use patents, MDMAs in the public domain.

00:39:55 ►

So that’s another difference in that Big Pharma wants drugs that they have patented.

00:39:59 ►

But what Reagan did is he created these incentives.

00:40:02 ►

So if you can make a drug into a medicine, even if there’s no patent protection,

00:40:07 ►

nobody can use your data for five years.

00:40:10 ►

And in Europe, it’s 10 years in order to market it as a generic.

00:40:14 ►

So there is this window of time that we’ll be able to probably be the only one selling MDMA.

00:40:20 ►

However, if some other company wants to make MDMA into a medicine,

00:40:24 ►

they can do so so and we would help

00:40:26 ►

them do it because we’re really more about this integration of psychedelics into cultures doesn’t

00:40:32 ►

have to be just us and the more people that do it the more now whether another company will do that

00:40:38 ►

I don’t think so because it’s going to cost them a bunch of money in a bunch of time they haven’t

00:40:42 ►

started yet and they might as well just wait till it goes generic. But in any case, we’re going to have this opportunity to go ahead

00:40:50 ►

and market MDMA. And so we’ve created a benefit corporation, and there’s probably 3,000 or 4,000

00:40:57 ►

benefit corporations right now, and they’re a modification on capitalism. So the problem with

00:41:03 ►

capitalism is that you maximize profits, but you don’t need to

00:41:07 ►

take into account externalities or social costs. You’re just looking at your own narrow company.

00:41:13 ►

And if minority shareholders think that the management is not maximizing profits,

00:41:18 ►

then they can vote the management out and get in people that are going to put profit first.

00:41:23 ►

So it’s like a cancer.

00:41:25 ►

It’s just got to grow and grow and grow and grow.

00:41:27 ►

And that’s what we see with a lot of economic growth.

00:41:32 ►

It’s not sustainable, nor should it be.

00:41:35 ►

But with a benefit corporation, what you do is you maximize social benefits, not profit.

00:41:41 ►

And so there is no concern about shareholders saying,

00:41:46 ►

you know, we want you to up the price

00:41:49 ►

and approve way more therapists,

00:41:51 ►

even if they’re not qualified,

00:41:52 ►

just to get more people out there doing it.

00:41:53 ►

So MAPS has created a benefit corporation,

00:41:56 ►

but it has only one investor,

00:41:59 ►

which is the nonprofit.

00:42:01 ►

So it’s another unique way to modify big pharma.

00:42:04 ►

So we’re going to be selling, MAPS is going to own the nonprofit. is the non-profit. So it’s a unique way to modify big pharma.

00:42:06 ►

So we’re going to be selling,

00:42:08 ►

MAPS is going to own the non-profit.

00:42:10 ►

I mean, MAPS owns the benefit corporation.

00:42:12 ►

People make donations to MAPS,

00:42:13 ►

get tax deductions.

00:42:15 ►

MAPS invests in the benefit corp.

00:42:18 ►

The benefit corporation sells MDMA,

00:42:20 ►

makes a profit,

00:42:23 ►

uses the profits for further research.

00:42:26 ►

So that’s the kind of virtuous cycle that we’re developing. So what I think where we’re at as far as reaching that goal is that at this end of phase

00:42:34 ►

two meeting with FDA, we presented data from 107 patients with PTSD. And what we found first off

00:42:42 ►

was that, and most importantly from the FDA’s point of view, is that we were able to administer MDMA safely, that there was no serious drug-related adverse events.

00:42:55 ►

Several of the people in our study had, more than a few, had previously attempted suicide from their PTSD.

00:43:02 ►

None of them continued to try to do that. We had nobody having, you know,

00:43:08 ►

psychotic breaks. We had an excellent safety profile. You know, there are risks from MDMA.

00:43:14 ►

People can overheat and die, even from pure MDMA. But that doesn’t happen in a clinical setting,

00:43:20 ►

where people aren’t dancing all night and where they’re getting fluids. Not just water. It’s better

00:43:26 ►

to drink

00:43:26 ►

stuff with electrolytes in it.

00:43:32 ►

we demonstrated safety.

00:43:36 ►

Then we shared with them

00:43:37 ►

what our results were.

00:43:39 ►

So basically our treatment is

00:43:41 ►

40 hours of psychotherapy.

00:43:44 ►

And the way these 40 hours are administered, it’s by a male-female co-therapist team.

00:43:50 ►

I had actually somebody at my previous talk come up to me and said,

00:43:53 ►

I’m transgender, and why are you saying male-female?

00:43:56 ►

There must be a non-binary way to do this, and we’ll try to figure that out.

00:44:01 ►

But the concept is that there’s two therapists, one maybe more male or female.

00:44:08 ►

The idea is that we’re trying to model a healthy family life

00:44:11 ►

because people get into very regressed states under psychedelics.

00:44:16 ►

And so if you’re sort of having issues with your childhood,

00:44:19 ►

it’s good to kind of have a very successful, well-worked-out male-female team.

00:44:24 ►

So that’s our treatment model, 40 hours of therapy.

00:44:27 ►

There’s 12 90-minute non-drug psychotherapy sessions,

00:44:31 ►

and there’s only three MDMA sessions.

00:44:34 ►

And they’re day-long sessions, eight hours long,

00:44:37 ►

and then the people spend the night in the treatment center,

00:44:40 ►

and then they’re resting, they’re reflecting,

00:44:42 ►

and the second day therapists come back and they have integrative psychotherapy

00:44:46 ►

to help them process what happened before.

00:44:48 ►

So we have three preparation sessions of 90 minutes,

00:44:53 ►

a day-long MDMA session with the overnight stay,

00:44:56 ►

then three more integrative sessions

00:44:57 ►

before the next MDMA session,

00:44:59 ►

which is three to five weeks apart,

00:45:01 ►

and we repeat that the third time,

00:45:02 ►

and then we measure people two months

00:45:04 ►

after the last MDMA session. And that’s called the primary outcome measure. to five weeks apart, and we repeat that the third time, and then we measure people two months after

00:45:05 ►

the last MDMA session. And that’s called the primary outcome measure. So the placebo people

00:45:10 ►

that just got the therapy without active MDMA, 23% of them no longer had PTSD.

00:45:18 ►

These are treatment-resistant, chronic, people who are severe to extreme, on average, were severe to extreme.

00:45:28 ►

And so just the therapy without any drugs was 23% effective, which is really pretty good.

00:45:34 ►

And so first off, it shows that we’re trying our best, even if they don’t get MDMA, to help them.

00:45:40 ►

Secondly, that the therapy can be effective.

00:45:47 ►

them. Secondly, that the therapy can be effective. But then when you add MDMA, after the second MDMA session, it was up to 55% no longer had PTSD. More than twice as good when you add MDMA for two

00:45:55 ►

sessions. But there’s a bunch of people that have more complex PTSD, more dissociation, they need

00:46:03 ►

more treatment. So we’ve added a third session and it’s up to 61% no longer have PTSD.

00:46:09 ►

But then the question is, is this durable?

00:46:12 ►

Is this something that maybe it’s this psychedelic afterglow that just lasts a short period of time?

00:46:19 ►

So we did a long-term follow-up at 12 months or longer, somewhere 3 1⁄2 years or more.

00:46:24 ►

long-term follow-up at 12 months or longer, somewhere three and a half years or more.

00:46:34 ►

And what we found is that the benefits actually increased over time. So at the long-term follow-up,

00:46:40 ►

two-thirds of the people no longer had PTSD. Now, we can’t say that’s all only from the MDMA,

00:46:45 ►

because they’re free to do other treatments, but MDMA opens people up to doing other treatments. So it’s clear that we have a durable effect that is profound, that works in

00:46:53 ►

people who have previously been unable to find relief, and that there was enough evidence in

00:47:00 ►

107 people of efficacy that we should move forward.

00:47:07 ►

And then the one other thing that we presented to the FDA was a little bit of an embarrassment for me

00:47:11 ►

because it was about how we’re going to address

00:47:15 ►

the double-blind problem methodologically.

00:47:17 ►

So I had thought that I solved the problem.

00:47:21 ►

And so a lot of my dissertation was about

00:47:24 ►

how to solve the double-blind problem,

00:47:26 ►

which obviously if you take a placebo or take an MDMA pill or an LSD pill, I bet you all of you

00:47:32 ►

could tell the difference. So how do you do this standard required FDA methodology of double-blind

00:47:39 ►

studies? And so the solution I thought was low doses. So some group gets therapy plus low doses,

00:47:45 ►

it’ll help them a little bit, but they’ll be confused because they’ll all get something

00:47:49 ►

happening and they won’t know is it the low dose or the full dose. And as long as we had confusion

00:47:54 ►

like that, that would count as the double blind. So I opened up the meeting with the FDA to say

00:48:00 ►

that one of my favorite quotes, the president of Harvard said,

00:48:03 ►

never forget there’s always a Harvard man on the wrong side of every issue.

00:48:10 ►

And so I said, in this case, it’s me.

00:48:12 ►

I thought I solved the problem, but in our actual research,

00:48:16 ►

what we found is that the low doses of MDMA, 25, 30, and 40 milligrams,

00:48:22 ►

actually had an anti-therapeutic effect.

00:48:25 ►

That people got stimulated.

00:48:27 ►

They started to try to process their trauma,

00:48:30 ►

but they didn’t have enough MDMA to have the fear reduction.

00:48:34 ►

And so it made them more uncomfortable.

00:48:36 ►

And so the people who had placebo inactive MDMA and the therapy,

00:48:42 ►

they got better by around a 20-point drop on the CAPS, the Clinician

00:48:47 ►

Administered PTSD Scale. But when you added low-dose MDMA, they still got better, but not

00:48:53 ►

nearly as much. So we said to the FDA, your model is this double-blind, placebo-controlled study,

00:49:00 ►

but the only way we can do it is to use low-dose MDMA to create enough confusion,

00:49:06 ►

but you’re going to actually make it easier for us to show a difference between the experimental

00:49:11 ►

group and the control group. And so we said, if you want us to do that, we will, but we recommend

00:49:16 ►

that we use an inactive placebo and the therapy. And people will know that the double-blind isn’t

00:49:22 ►

working. They’ll be able to tell, but that’s still the better way to do it.

00:49:26 ►

And that’s what we proposed to the FDA.

00:49:29 ►

And so at the end

00:49:30 ►

of the meeting, they

00:49:31 ►

said, yes,

00:49:34 ►

you can go to phase three.

00:49:36 ►

And we had pre-planned

00:49:37 ►

this. We had a New York Times article that came out

00:49:39 ►

the very next day. And so we

00:49:41 ►

announced to the world that now we’ve been approved

00:49:44 ►

to go to phase three

00:49:45 ►

and so what we then decided to do was to engage the fda in a process what’s called special

00:49:56 ►

protocol assessment so not a lot of sponsors use it because it takes about six more months and

00:50:02 ►

sponsors from big pharma are trying to get their patented drugs approved as quickly as they can while their patent is still going.

00:50:09 ►

So after we were approved for Phase 3, we could have gone, designed our Phase 3 study

00:50:14 ►

and started, but we felt it was much better to enter this new program where what you’re

00:50:20 ►

basically doing is you’re reviewing the protocol with FDA, every aspect of the design, even down to the formula for your statistical analysis plan.

00:50:28 ►

They even caught where we had used a minus sign that should have been a plus sign.

00:50:33 ►

So I was super impressed with their review.

00:50:35 ►

And in the end, we came to agreement, and they said, yes, you can do inactive placebo.

00:50:42 ►

Yes, you can do this model with three MDMA sessions.

00:50:46 ►

Yes, you can use the caps as your primary.

00:50:49 ►

All the different things.

00:50:50 ►

And so on July 28th, FDA sent us a letter saying,

00:50:55 ►

a formal agreement letter for the special protocol assessment.

00:50:59 ►

So that was the real key that we could move now into Phase 3

00:51:03 ►

with understanding on

00:51:05 ►

the design and what that means this agreement letter is that if we do the

00:51:09 ►

study with this design and get statistically significant evidence of

00:51:13 ►

efficacy and safety the FDA will approve the drug so it eliminates worries about

00:51:19 ►

Trump trying to shut it down or anything like that.

00:51:27 ►

It’s pretty impressive.

00:51:36 ►

The only concern is that if you develop some evidence of a new safety issue,

00:51:38 ►

then the FDA can take that into account.

00:51:42 ►

But with tens of millions of people who have already taken MDMA,

00:51:46 ►

we don’t think it’s very likely that we’re going to discover some new safety concern.

00:51:50 ►

So we’re pretty comfortable that with this design, with this protocol, we will be able to move forward and get the drug approved.

00:51:53 ►

But, yes?

00:51:55 ►

I’m curious.

00:51:56 ►

So if that happens, what happens to the scheduling then?

00:52:01 ►

Is that like good grounds for clearing that up, or is it automatic?

00:52:04 ►

Yeah.

00:52:04 ►

So the Controlled Substances Act was created in 1970 and that’s what criminalized

00:52:10 ►

all sorts of drugs and set up the schedules. And luckily back in 1970, the regulators,

00:52:17 ►

the people in Congress were a little bit suspicious of the police authorities and their

00:52:22 ►

willingness to try to shut down research. And so what the Controlled Substances Act says is that if the FDA says a Schedule I drug is a medicine,

00:52:32 ►

the DEA must reschedule.

00:52:35 ►

They can decide which schedule it goes in, but they must move it at least to Schedule II.

00:52:41 ►

They have no option whatsoever to not do that.

00:52:45 ►

So that’s really crucial to us.

00:52:48 ►

So that’s another step that it will happen.

00:52:50 ►

And what we’re proposing, as it becomes a medicine,

00:52:54 ►

we’re proposing that it only be administered by therapists that we’ve trained.

00:52:59 ►

And the FDA is wanting that too,

00:53:01 ►

that it’s only been proven safe and effective in MDMA plus

00:53:06 ►

psychotherapy. So only those people that we trained will prescribe it and only on an inpatient

00:53:12 ►

or a residential basis. People aren’t going to have to spend the night in the treatment

00:53:17 ►

center, but it’s not going to be take-home medicine where people can do it on their own.

00:53:21 ►

So from the point of a DEA, well, I don’t think it’ll ever become a take-home medicine.

00:53:27 ►

It will become a legal drug

00:53:28 ►

before it becomes a take-home medicine, I think.

00:53:31 ►

What about your license?

00:53:34 ►

Well, okay, let me go back one second

00:53:38 ►

to say that there’s one other program that the FDA has,

00:53:42 ►

which we decided to go for.

00:53:44 ►

And it’s a program that the FDA has, which we decided to go for. And it’s a program that the FDA has

00:53:46 ►

developed to look at the most promising drugs and identify them and then make them in a special

00:53:54 ►

program which expedites their development. You get extra FDA help. You get the meetings, more

00:54:00 ►

meetings with them. The meetings are shorter. They have to respond to you in a shorter time frame. And that’s called breakthrough therapy.

00:54:07 ►

And there used to be Fast Track.

00:54:09 ►

There used to be other programs.

00:54:11 ►

But breakthrough therapy is now…

00:54:14 ►

Yeah.

00:54:20 ►

So, yes, breaking the sound barrier and breakthrough therapy are kind of similar.

00:54:27 ►

So I was concerned.

00:54:29 ►

I knew that we met the qualifications for breakthrough therapy,

00:54:33 ►

but I was concerned that the FDA might not give it to us because it’s very public.

00:54:38 ►

And the fact that we have this agreement letter for the special protocol assessment,

00:54:43 ►

that was the crucial thing that gave us the sense, yes, we can go forward to phase three with this design. But breakthrough

00:54:50 ►

therapy gives a lot of other advantages. And so we applied for breakthrough therapy. And

00:54:56 ►

I think I just want to highlight the fact that the FDA has not only…

00:55:06 ►

Actually, there was planes buzzing on Tuesday night.

00:55:09 ►

I don’t know if you saw that, too.

00:55:11 ►

It’s $10,000 an hour just for the gas.

00:55:17 ►

So…

00:55:17 ►

And these are military planes.

00:55:20 ►

So, at least…

00:55:21 ►

We do have friends in the DOT.

00:55:25 ►

So we applied for breakthrough therapy.

00:55:27 ►

And as of August 15th, FDA said yes, they’ve granted us breakthrough.

00:55:38 ►

So they have demonstrated courage, not just a focus on science,

00:55:44 ►

but a political courage to do that in such a public way.

00:55:47 ►

And we decided that we would not make that public,

00:55:50 ►

but we gave exclusives of the Washington Post to report it.

00:55:54 ►

And so last Sunday, the Sunday of Burning Man starting,

00:55:58 ►

it was front page of the Washington Post that FDA had granted breakthrough therapy.

00:56:03 ►

page of the Washington Post that FDA had granted breakthrough therapy.

00:56:11 ►

And we also had an article in Science.

00:56:15 ►

But for our political strategy, we’re now working on an article for Breitbart.com. And it’s crucial

00:56:19 ►

that we do that. We’ve had articles in Military.com, Stars and Stripes,

00:56:24 ►

the Navy SEALs website,

00:56:27 ►

RedState.com.

00:56:28 ►

Really, we need

00:56:29 ►

to be building bipartisan support.

00:56:32 ►

And so, we are doing

00:56:33 ►

that. And things are really moving

00:56:35 ►

forward in a great way. So, now

00:56:37 ►

that we have Breakthrough, now that we have

00:56:39 ►

the Special Protocol Assessment,

00:56:42 ►

we’re going forward

00:56:44 ►

starting as soon as we get back from Burning Man in September and October.

00:56:49 ►

We’re starting a protocol that’s not the phase three study itself, but it’s called a phase two open label study.

00:56:58 ►

And the primary purpose is for the training of the therapists.

00:57:01 ►

So basically we’re embarking on a $25 million experiment. And what will determine

00:57:08 ►

whether this works or not is the MDMA itself. We’re spending a million dollars to get medical

00:57:15 ►

grade MDMA and stick it in capsules, which shouldn’t be that hard or that expensive, but

00:57:20 ►

meeting FDA standards. And we to produce the the pharmaceutical drug that

00:57:25 ►

we would market after approval and use that in phase three so you’re sort of

00:57:32 ►

jump-starting a lot of expenses to do that but what we’ve been able to do it

00:57:39 ►

really will depend upon a lot of the therapists and how well they operate

00:57:43 ►

with the patients we We do think from

00:57:45 ►

our early phase two research that the drug is more important than the therapy. And that’s what we

00:57:52 ►

showed, 23% after the therapy, but up to 61% after three with the MDMA. So the problem with our

00:58:00 ►

program of training therapists has been that the way you train therapists is they work

00:58:05 ►

with patients and you get supervision and then you give them feedback and they work with more patients

00:58:09 ►

but because we’re using an illegal drug the only way that we can actually have them work with

00:58:15 ►

patients is in the context of a protocol and so we worked with FDA and we said we want this phase

00:58:22 ►

two protocol no double blind it’s for gathering data, but it’s primarily for the purpose of training these new therapists.

00:58:29 ►

So Cole will be one of them.

00:58:31 ►

We have a bunch of others.

00:58:32 ►

We have 40 male-female co-therapist teams.

00:58:35 ►

We’ve trained about 80 people, 40 teams at 14 different sites throughout the United States, Israel, and Canada.

00:58:44 ►

And some of these therapists have worked on Phase two, but a lot of them have not.

00:58:48 ►

So every NUCO therapy team is going to be able to work with one patient under direct supervision.

00:58:55 ►

And that’s going to cost us about another million dollars.

00:58:58 ►

But I think that’s like an insurance policy that will really have all these therapy teams ready to go.

00:59:03 ►

policy that will really have all these therapy teams ready to go.

00:59:10 ►

And in April of 2018, we’re going to be starting the phase three study.

00:59:17 ►

And we anticipate that by the end of 2019, early 2020, we will have completed treating all the patients and we’ll have the data to start negotiating with FDA.

00:59:22 ►

And we think by 2021, we’ll have MDMA approved as a prescription medicine.

00:59:30 ►

And there are other groups, the Hefter-Usona group that Steve is part of,

00:59:36 ►

Steve Ross from NYU, and others,

00:59:39 ►

that they’re going to be working to medicalize psilocybin.

00:59:42 ►

And so more and more, we’re sharing staff, sharing our insights

00:59:47 ►

with the FDA. So just as the way we talk about psychedelics producing the sense of unity,

00:59:52 ►

the psychedelic researchers are now at a new stage of unity. We have some disagreements about how

00:59:59 ►

much we should criticize the drug war, but those are kind of less important than all the ways in which we’re

01:00:06 ►

sharing information and sharing skills. So we think by 2021, we’ll be able to have psychedelic

01:00:12 ►

clinics. People will be trained, cross-trained for both MDMA and psilocybin. They can also be

01:00:17 ►

working with ketamine, which is already being used for depression. Most of the time, ketamine is used

01:00:22 ►

without therapy. It’s just as a pharmacological treatment and so

01:00:25 ►

there’ll probably be ways to add more therapy in these clinics but there’s because we have

01:00:31 ►

breakthrough because there’s such an enormous need for the treatment of ptsd we have 18 000 people

01:00:37 ►

have contacted us on their website to be notified when the ptsd study starts because they want to volunteer for the study.

01:00:48 ►

18,000 people already have come to us.

01:00:50 ►

So there’s a tremendous need.

01:00:52 ►

And what the FDA has another program,

01:00:54 ►

which is called Expanded Access,

01:00:57 ►

and the Republicans love this program,

01:01:00 ►

and they’ve done a lot that’s called Right to Try.

01:01:03 ►

So it’s in a way part of a libertarian approach.

01:01:04 ►

It’s a deregulation approach.

01:01:05 ►

But the basic idea is that if you have any kind of condition and the currently available medicines have not helped you

01:01:11 ►

and there is a medicine for your condition that’s being reviewed by the fda but the review hasn’t

01:01:17 ►

completed you should have a right to try those drugs and so there’s 25 states or so that have passed these right-to-try laws.

01:01:25 ►

But the FDA already has this expanded access program. And what that means is that if your

01:01:31 ►

phase three studies are filled up and there’s no waiting list, you’re moving forward as quickly as

01:01:36 ►

possible, all these, I mean, you have a waiting list, all these people on the waiting list can

01:01:42 ►

go into expanded access, which means they can pay for the therapy.

01:01:46 ►

The pharmaceutical company sponsor can only charge the cost of the drug.

01:01:51 ►

You can’t make a profit.

01:01:52 ►

They don’t want companies making a profit before it’s approved.

01:01:55 ►

But you can get your cost recovered. And likely, I think, that by the summer to the end of 2019,

01:02:08 ►

we’re going to train a whole bunch of new therapists,

01:02:13 ►

particularly to be working in cities where we’re not having Phase III sites,

01:02:17 ►

and they can then treat people on an expanded access basis.

01:02:23 ►

And we will be gathering safety information but not efficacy because, again, there’s no double blind.

01:02:27 ►

So it won’t count for how the FDA decides whether to approve the drug,

01:02:33 ►

but it will develop our safety database and also make the drug available.

01:02:38 ►

The question is where are our Phase III sites?

01:02:47 ►

We have sites in Vancouver, in Montreal, two sites in San Francisco, one site in L.A., a site in New Orleans, a site in Boulder, a site in Fort Collins,

01:02:51 ►

a site in Madison, Wisconsin, two sites in New York, the University of Connecticut,

01:02:58 ►

one site in Charleston, South Carolina.

01:03:02 ►

And then we’re still trying to figure out one or two sites in Israel,

01:03:06 ►

definitely outside of Tel Aviv, at least one site and maybe two.

01:03:12 ►

Okay, yes, yes, there’s loads of PTSD in San Diego and loads of military people.

01:03:17 ►

But what we’re doing is we’re building everything around the therapists.

01:03:22 ►

The therapists are the crucial thing.

01:03:26 ►

And also we wanted cities where there were a lot

01:03:28 ►

of PTSD and also potential donors

01:03:30 ►

in some of the cities.

01:03:32 ►

So it was strategically chosen

01:03:34 ►

for multiple reasons. So San

01:03:36 ►

Diego would be like an expanded access

01:03:38 ►

site. Because we’ve got enough

01:03:40 ►

people trained

01:03:42 ►

for phase three.

01:03:44 ►

Alright. Yeah. Where would I have to go for a therapist? enough people trained for phase three. All right.

01:03:45 ►

Yeah.

01:03:48 ►

Where would I refer a therapist to?

01:03:51 ►

It’s like I refer somebody that I’m not very good at.

01:03:52 ►

Okay.

01:03:55 ►

So the question is, where would you refer a therapist to be trained?

01:03:58 ►

Well, if you go to the MAPS website,

01:04:03 ►

and there’s a section that says, menu bar says participate,

01:04:06 ►

there’s a way for therapists to sign up to be on the mailing list and so what we think is that our therapy training team the most important thing

01:04:13 ►

that they’re going to be doing starting in this open label phase two study and then in the early

01:04:18 ►

stages of phase three is going to be watching the videotapes and giving feedback to the therapists

01:04:23 ►

about how they’re doing.

01:04:31 ►

And so near the end of 2018 is when we think we’re going to start training for expanded access.

01:04:39 ►

And as part of the training, just to say it’s two week-long in-person sessions. The first week is looking at our treatment manual, which is on the website, to see how we describe the therapy,

01:04:45 ►

and then mostly watching videotapes of therapy sessions. The second week is more videotapes,

01:04:51 ►

more talking about the treatment manual, but also we’ve done holotropic breath work to help

01:04:56 ►

everybody sort of experience non-ordinary states, and also work on teamwork and role play for

01:05:02 ►

teamwork. And in addition to that, we went to the FDA and we said,

01:05:08 ►

we really feel that there’s a missing link here,

01:05:10 ►

is that when you want to study yoga, you go to a yoga teacher who’s practiced yoga.

01:05:15 ►

You want to study meditation, you go to a meditator, a teacher who meditates.

01:05:20 ►

But when you want to go to a psychedelic therapist,

01:05:22 ►

ideally you’d want to go to one that’s done the psychedelics.

01:05:26 ►

But unless we have somehow a legal permission to give MDMA to the therapist, we’re not going to be able to train them properly.

01:05:33 ►

And so the FDA said, we understand your situation.

01:05:37 ►

We can’t just give you permission to give MDMA to a therapist. But if you design a scientific protocol that gathers some information, and we don’t care what,

01:05:46 ►

we’ll let you limit who volunteers for your study to therapists in your training program.

01:05:52 ►

So about five years ago, we got that.

01:05:54 ►

And we’ve treated over 30 people from all over the world now.

01:05:57 ►

We can bring in people to give them an MDMA session.

01:06:01 ►

And then the last is working under supervision.

01:06:03 ►

So somewhere near the end of 2018, we’ll start the training programs again.

01:06:07 ►

What kind of psychotherapy do therapists provide?

01:06:11 ►

Is it EMDR or is it basic psychotherapy?

01:06:14 ►

Because I do a mixed therapy.

01:06:16 ►

I’ve done a mixed therapy EMDR, but I’ve been calling it math to help heal.

01:06:22 ►

Yes, there’s EMDR, which is eye movement desensitization and reprogramming.

01:06:30 ►

There’s a variety of techniques for the treatment of PTSD.

01:06:35 ►

Some are called prolonged exposure, cognitive processing therapy,

01:06:38 ►

cognitive behavioral.

01:06:40 ►

We can use elements of those.

01:06:42 ►

We don’t ever use EMDR.

01:06:44 ►

We don’t use guided imagery.

01:06:46 ►

The core aspect of our method is a respect for what we’re sort of calling the inner healer.

01:06:54 ►

So what we say is, and what we all know is, you hurt your body, and your body knows how to heal itself.

01:06:59 ►

We don’t know how to do it.

01:07:00 ►

Somehow there’s some wisdom in here that heals the scratch or heals the broken bone.

01:07:07 ►

And we are assuming that there’s something similar in the psyche

01:07:11 ►

and that there’s impediments that block the healing process

01:07:15 ►

and repetitive patterns and fears and all sorts of cultural programming that get in the way.

01:07:20 ►

But the thought is that under the influence of psychedelics mdma lsd ayahuasca that there’s

01:07:26 ►

an emergence into awareness from the unconscious that is more individually designed according to

01:07:34 ►

what you really need and that it’s the job of the therapist not to be the guide we don’t use a lot

01:07:39 ►

of people say i’ll be your guide we don’t use the word guide because that implies somehow that the

01:07:43 ►

therapist know where to go and really it’s the patient guide because that implies somehow that the therapists know where to go.

01:07:45 ►

And really it’s the patient’s unconscious.

01:07:47 ►

So we support that process.

01:07:50 ►

Yeah.

01:07:50 ►

I’m trying to feel back to onion, but I have complex PTSD.

01:07:55 ►

So the EMDR has slowly peeled back.

01:07:59 ►

Yeah.

01:07:59 ►

What’s going on?

01:08:00 ►

Is it seriously in the air?

01:08:02 ►

Yeah.

01:08:03 ►

It’s helpful.

01:08:05 ►

But when you’re doing research, too, you have to have one intervention.

01:08:09 ►

So you can say that’s what did it.

01:08:12 ►

So if we were to combine EMDR, all of these things,

01:08:16 ►

then the question would be what was the effective part.

01:08:20 ►

And what we have to show is that the therapy that we do without the MDMA

01:08:24 ►

is fundamentally enhanced by the therapy with MDMA.

01:08:27 ►

But once it’s a prescription medicine,

01:08:30 ►

and again, the only people that are going to be able to prescribe it

01:08:33 ►

are people that have been through our training program.

01:08:35 ►

That’s going to be a requirement of the FDA.

01:08:37 ►

But once it’s approved and people have been trained in our method,

01:08:41 ►

then they’re free to modify it however they want.

01:08:44 ►

So let’s say you wanted to do EMDR while somebody was under the influence of MDMA.

01:08:48 ►

You could do that.

01:08:50 ►

Yeah.

01:08:51 ►

You might not need it.

01:08:52 ►

There was a – the military has been doing a lot of work with virtual reality,

01:08:57 ►

and they will present kind of scenes to people who have been traumatized,

01:09:02 ►

but the advantage is you can sort of shut it off when you

01:09:05 ►

want, and they tried to make it somewhat similar to what people had. There was a conference in

01:09:09 ►

Israel in 2009 with a woman with PTSD, and there was a woman, Edna Foa, who developed prolonged

01:09:16 ►

exposure, which is one of the main treatments for PTSD, and she’s kind of old school, and she’s like,

01:09:22 ►

why are you using MDMA? It’s like dynamite in the brain.

01:09:26 ►

You know, she didn’t know the difference between LSD or MDMA, and she was scared of all of it.

01:09:31 ►

And so, and she just said, you know, try something like virtual reality. And there was a guy, Skip

01:09:37 ►

Rizzo, funded by the military to develop virtual reality for PTSD. And he was at the conference.

01:09:42 ►

So I went to talk to him. And I said, you know, Edna tells me, forget about MDMA.

01:09:47 ►

I should try virtual reality for PTSD.

01:09:49 ►

So how’s it going with you?

01:09:51 ►

And he laughed.

01:09:51 ►

And he said, if you have MDMA, you don’t need virtual reality.

01:09:59 ►

Yeah.

01:10:01 ►

Yeah.

01:10:01 ►

Yes.

01:10:02 ►

MDMA really is more specifically localized to your own emotions.

01:10:07 ►

It’s personally customized, and it reduces the fear.

01:10:16 ►

Yeah, you see?

01:10:17 ►

Yeah, so I think that we are on the track towards making it into a medicine.

01:10:24 ►

We will have this opportunity in 2019

01:10:27 ►

for this expanded access. And then the key issues, once it’s approved, so this is the kind of

01:10:32 ►

challenges where we still have negotiations to go with FDA and how we imagine that. So the

01:10:40 ►

first thing that we’re going to negotiate, the FDA wants to know the commercialization plan,

01:10:46 ►

is how many therapists are going to be trained, what’s the number of patients, what’s the amount of MDMA, all of that.

01:10:53 ►

Bonnie?

01:10:54 ►

Just a question.

01:10:56 ►

You mentioned on the right to try, there would be additional therapists trained.

01:11:08 ►

Rick, referring back to your mentioning of the right to try,

01:11:12 ►

and we’ve got 18,000 people interested in the study,

01:11:18 ►

and additional therapists would be trained outside of the study.

01:11:21 ►

Where is the funding for that? Is that FDA funding for the training for those therapists, or is that MAPS?

01:11:26 ►

That’s MAPS.

01:11:26 ►

No, no, FDA funds the critique, not the creation.

01:11:32 ►

Okay, so, okay, I understand.

01:11:35 ►

Yeah, so we’re going to have to, and so at some point,

01:11:39 ►

once there’s a real field that people can practice,

01:11:43 ►

we’ll be charging for the training.

01:11:47 ►

Right now, we ask people to donate their time, but we cover all the expenses of their travel,

01:11:53 ►

the room and board.

01:11:54 ►

There’s no charge for the training.

01:11:58 ►

Wonderful.

01:12:02 ►

Thank you.

01:12:03 ►

So, again, just in terms of your approval and your post-approval strategy,

01:12:07 ►

I’ve heard a lot about clinical trials, open-label extensions,

01:12:10 ►

which are fantastic, of course, high-quality evidence, but very expensive.

01:12:14 ►

And given two things.

01:12:16 ►

First off, given that MAPS is a nonprofit with limited resources,

01:12:19 ►

and given FDA’s increasing openness to real-world data and observational data under Purdue FAS 6,

01:12:21 ►

FDA’s increasing openness to real-world data and observational data under

01:12:23 ►

Purdue for six. I’m curious if you guys

01:12:26 ►

have thought about observational or real-world

01:12:28 ►

data studies on three fronts.

01:12:30 ►

So first off, potential label expansions

01:12:32 ►

once you do receive approval

01:12:34 ►

for moderate to severe PTSD.

01:12:36 ►

Second, post-marketing

01:12:38 ►

safety commitments. And third,

01:12:40 ►

potentially payer evidence down the road.

01:12:42 ►

Yes. Those are all really

01:12:44 ►

crucial questions. So I’ll start with payer evidence.

01:12:46 ►

So we tried to negotiate with Kaiser

01:12:48 ►

to have one of our sites in Oakland be at Kaiser.

01:12:51 ►

So ultimately it did not work,

01:12:54 ►

but Kaiser will be referring patients to us.

01:12:56 ►

So the key point is that when you have PTSD,

01:13:00 ►

the stress of that causes all sorts of other health consequences and ptsd patients are expensive

01:13:08 ►

to the insurers so we’re working with the head of pharmacoeconomics at harvard medical school

01:13:15 ►

who’s helped us put some measures of health care utilization in the clinical trials but it’s not

01:13:21 ►

going to be enough because it’s only short term. So you need sort of long term data like that. So we are trying to put into place mechanisms because the key point,

01:13:30 ►

again, with insurance is there’s a lot of people that cannot afford this treatment but need it.

01:13:36 ►

And most of the people that need it can’t afford it. And so to really roll it out, we’re going to

01:13:41 ►

have to persuade insurance companies to cover it. And so that’s really crucial.

01:13:45 ►

The idea of label extensions and observational studies,

01:13:50 ►

that’s going to be part of this very important negotiations about off-label prescriptions.

01:13:59 ►

And so that’s, I think, one of the top negotiating items that we still have to go.

01:14:03 ►

What off-label prescriptions mean is the drug is prescribed.

01:14:08 ►

You do the research for one thing.

01:14:10 ►

The key, FDA is already asking us to work on the label.

01:14:13 ►

The label is what sort of goes on the bottle, what says this drug is for this thing.

01:14:19 ►

And these are the side effects and these are the concerns.

01:14:21 ►

But it’s approved for this thing which will be ptsd and

01:14:25 ►

insurance will cover that but we’ve also done small not observational studies but small phase

01:14:31 ►

two pilot studies with autistic adults with social anxiety and we’ve gotten tremendous results on the

01:14:37 ►

reduction of social anxiety and we’ve done studies with mdma for life-threatening illnesses people

01:14:44 ►

who are anxious about dying.

01:14:46 ►

And there’s a whole host of uses that we’re even thinking about for anorexia, for body image,

01:14:53 ►

for racial trauma, trauma from sexual identity, for just outright depression and anxiety.

01:15:00 ►

There’s a whole host of things.

01:15:02 ►

So the key question is going to be to what extent will FDA permit us to do off-label,

01:15:09 ►

and how does that interact with what people are doing in underground settings?

01:15:19 ►

Also, I’m thinking further to get approval for those additional indications.

01:15:22 ►

So, for instance, in the oncology space where there are a lot of breakthrough therapy designations,

01:15:27 ►

FDA is somewhat more open to more innovative trial designs.

01:15:30 ►

For instance, using historical controls where you just treat one arm

01:15:34 ►

and then you use, essentially, observational data from pre-existing trials

01:15:37 ►

to augment those data, again, in the interest of speed and efficiency.

01:15:42 ►

So, again, just innovative approaches to expand the universe of potential treatments.

01:15:46 ►

Yeah.

01:15:47 ►

No, those are what we are going to be engaging FDA in negotiations with.

01:15:51 ►

The problem and the difference, I would say, with oncology drugs is we’ve got a Schedule

01:15:54 ►

1 drug that’s widely used in recreational settings.

01:15:58 ►

So there may be some pushback that we get from FDA and certainly from DEA about off-label

01:16:04 ►

prescriptions.

01:16:05 ►

But from a historical point of view, in 1986, when Marinol, the oral THC pill, was approved

01:16:11 ►

as a medicine, the DEA said they didn’t want anybody prescribing it for anything else other

01:16:17 ►

than nausea control for cancer chemotherapy, which was what was on the label.

01:16:22 ►

And they have to publish these rules in the Federal Register,

01:16:26 ►

and there’s 30 days to comment.

01:16:28 ►

And so the American Pharmaceutical Manufacturers Association,

01:16:31 ►

the AMA, and other groups objected to the limitation of off-label prescription

01:16:37 ►

on the basis that this was a Schedule I drug.

01:16:40 ►

And the DEA had to withdraw the ruling.

01:16:43 ►

So there’s really a precedent that even though it’s a Schedule I drug,

01:16:48 ►

off-label should not be restricted.

01:16:51 ►

But then this is where we sort of touch in observational studies.

01:16:55 ►

So if somebody prescribes it for something other than PTSD,

01:17:00 ►

we would like to know what are they prescribing it for.

01:17:03 ►

And so there may be some negotiation that goes forward where off-label is permitted,

01:17:09 ►

but there’s some kind of data gathering process so that if there’s enough examples of MDMA being used for other things,

01:17:17 ►

either that will trigger us to do another either phase three or phase two study,

01:17:21 ►

but we’ll sort of, I think think as the expansion of off-label

01:17:25 ►

prescription, there’ll be some sort of

01:17:27 ►

quasi-observational studies

01:17:29 ►

going on within that context.

01:17:32 ►

I think that’s how it’ll do it.

01:17:34 ►

And then…

01:17:35 ►

We would love to…

01:17:39 ►

Okay, where are you

01:17:41 ►

located?

01:17:46 ►

Okay, well let’s talk after Okay, well, let’s talk afterwards.

01:17:48 ►

Because, yeah, I think that’s really crucial.

01:17:51 ►

As founder of the Chicago Healthcare Ventures, we invest in healthcare companies.

01:17:56 ►

One of the markets we’re looking at is behavioral health, and it’s chaotic.

01:18:00 ►

So as an entrepreneur, one of my visions is to open up an MDMA treatment center,

01:18:06 ►

which is going to be a couple years out.

01:18:09 ►

So what do you recommend how I can get involved today?

01:18:18 ►

Well, I would say that one of the things you could get involved today with is to think about opening up a ketamine clinic.

01:18:22 ►

And you can talk to Cole about that because that’s something you can implement today. The other thing is to think about what other treatments would be good for people, massage, flotation tanks, different kind

01:18:32 ►

of counseling. And so you could open up a center like that. But I think the other thing is to

01:18:37 ►

consider trying to locate people who you think would be or yourself would be good therapists

01:18:43 ►

and then get them in line for us to be starting to train them.

01:18:47 ►

So I think the important point here is that there is likely to be requirements

01:18:56 ►

that MDMA is only administered in these clinical settings and never as a take-home drug.

01:19:02 ►

And that we’ll eventually have thousands of these all across America

01:19:06 ►

and that we’re going to want to, MAPS will do a few of them

01:19:09 ►

to sort of set a standard of care,

01:19:11 ►

but we want loads of other people to set up their own clinics.

01:19:15 ►

So I think building contacts with people in the PTSD research community,

01:19:22 ►

Chicago is where you’re at,

01:19:23 ►

PTSD research community, Chicago is where you’re at,

01:19:31 ►

trying to think about being an expanded access site.

01:19:34 ►

So I think the main thing is the training to be therapists,

01:19:36 ►

getting therapists who can go through the training.

01:19:38 ►

You can think about the economics of a clinic center,

01:19:41 ►

starting, I think, with ketamine.

01:19:43 ►

And then eventually it will expand.

01:19:46 ►

You get ketamine, flotation tanks, and massage.

01:19:49 ►

And then you just naturally roll it out to MDMA and psilocybin.

01:19:51 ►

Yeah.

01:19:55 ►

But that’s great because really it’s about trying to – we want to do everything in a nonprofit context,

01:19:58 ►

but there’s lots of opportunities for for-profit companies

01:20:02 ►

and businesses to be established, and we want to encourage that

01:20:06 ►

Yeah, I want to go back to one of your other questions though, which is expanding the label

01:20:11 ►

So this is going to be a surprise. I think to all of you, but the FDA is

01:20:17 ►

Requiring us to do studies in adolescence

01:20:20 ►

With PTSD. It’s not that we had to argue to the FDA.

01:20:25 ►

There’s a bunch of people.

01:20:27 ►

We actually had a mother,

01:20:33 ►

when we were doing the first MDMA study,

01:20:36 ►

say that her daughter had been raped at a young age

01:20:39 ►

and was mute.

01:20:40 ►

And she was only 16.

01:20:42 ►

It was earlier, but she was 16 at the time.

01:20:45 ►

And so we applied to the FDA for an exception to enroll her in the study.

01:20:50 ►

And the FDA said no, we had to complete the study in adults first.

01:20:54 ►

But there are so many drugs that are approved by the FDA

01:20:57 ►

that are being used off-label in kids

01:20:59 ►

that the FDA now, unless there’s some real toxicity issue,

01:21:04 ►

like sometimes with cancer drugs,

01:21:06 ►

they’re requiring sponsors to come up with a plan for doing study in adolescents.

01:21:11 ►

So we’re actually requesting a waiver that we don’t have to do studies between 0 and 11 ages,

01:21:21 ►

and the methods of measuring PTSD are not validated in those ages anyway but we’re going to be proposing

01:21:27 ►

12 to 17 we can already

01:21:28 ►

go down to 18

01:21:29 ►

and we’ve negotiated successfully

01:21:33 ►

that we don’t have to start that study

01:21:34 ►

until after the drug is approved

01:21:36 ►

so there will be another series

01:21:38 ►

of discussions and negotiations with

01:21:40 ►

FDA on additional

01:21:42 ►

studies the other question that the

01:21:44 ►

FDA is going to want us

01:21:45 ►

to address is, what about the fact that we have three MDMA sessions, we have these 40 hours of

01:21:51 ►

therapy, but some people might need a fourth session. And some people might be successfully

01:21:56 ►

treated for their PTSD, but then five years later, some other traumatic incident happens,

01:22:03 ►

and then they got PTSD again.

01:22:11 ►

So we’re going to have to be looking at in some negotiated form with the FDA about what do we do about additional sessions beyond what we’ve studied and then also what do we

01:22:16 ►

do about sort of people who relapse and how do we give them sessions.

01:22:20 ►

So those will be part of our phase four commitments to be starting to look at that.

01:22:23 ►

So those will be part of our phase four commitments to be starting to look at that.

01:22:31 ►

And I think that from what we’ve seen from FDA and also what we know from DEA,

01:22:34 ►

that this is like a dream for them compared to medical marijuana.

01:22:40 ►

Medical marijuana is a nightmare because from their regulatory control perspective, because people get a month’s supply, they go home and they do it,

01:22:43 ►

and they can give it to their friends, and who knows where it goes,

01:22:45 ►

and does it stay medical or not.

01:22:48 ►

But with MDMA, with psilocybin, with ketamine,

01:22:51 ►

they’re only administered by the therapist or the doctors under direct supervision.

01:22:55 ►

So a lot of these regulatory issues are going to be relatively easy for us to address

01:23:00 ►

because we do believe that the therapeutic component needs to be provided

01:23:05 ►

at the same time.

01:23:10 ►

So on that, you said in the past, and I’ve long subscribed to this, your idea and your

01:23:17 ►

vision of the psychedelic centers and this idea of getting a license, but you just mentioned

01:23:23 ►

that you think that maybe it won’t be available for take-home use.

01:23:28 ►

So where do you stand on your psychedelic license?

01:23:32 ►

Okay, yes.

01:23:33 ►

Great.

01:23:34 ►

Thank you for that.

01:23:35 ►

Okay, so let’s say we’ve got these behavioral health centers.

01:23:39 ►

One thing we’re doing right now with the VA. So far, the VA has not formally wanted to work with us,

01:23:50 ►

but they’ve been very interested in tracking what’s going on with MDMA. And through the

01:23:55 ►

intervention of Senator Rockefeller, who was on the Senate Veterans Affairs Committee, and Richard

01:23:59 ►

Rockefeller, his cousin, who is head of the Board of Advisors and Doctors Without Borders,

01:24:05 ►

his cousin, who is head of the Board of Advisors and Doctors Without Borders, we’ve had a series of negotiations with the Department of Defense and the VA.

01:24:09 ►

And out of that came this sense that if we funded studies with VA-affiliated therapists,

01:24:17 ►

they would permit them to do these studies.

01:24:20 ►

The therapists would do them with their academic affiliations, not their VA affiliations.

01:24:25 ►

And the first one they wanted us to start was a method of therapy called cognitive behavioral conjoined therapy.

01:24:33 ►

So conjoined means couples therapy.

01:24:35 ►

So it’s couples therapy where one member has PTSD and it affects the relationship.

01:24:42 ►

And so they engage both members of the couple in the therapy.

01:24:45 ►

So we said, that’s great.

01:24:47 ►

We’ll fund that.

01:24:47 ►

Let’s do that.

01:24:48 ►

But then we went to the FDA, and we said, we would like to give both members of the couple MDMA,

01:24:54 ►

not just the PTSD patient.

01:24:56 ►

And the FDA said yes.

01:24:59 ►

So this is now the first time that we have a non-patient receiving MDMA in a therapeutic study.

01:25:10 ►

What we’re thinking of with the clinics, let’s say that you will be treating the patients,

01:25:17 ►

but you will also be able to expand to treat some of the family members who are affected by it.

01:25:24 ►

Then eventually, when the culture, and so this is the big picture,

01:25:29 ►

when eventually the culture gets more comfortable,

01:25:32 ►

there’ll be people that want personal growth experiences that are not patients.

01:25:38 ►

And so one way to ease into a culture that is very, you could say, traumatized and scared about psychedelics in large ways is to think about these centers as like sites of initiation.

01:25:56 ►

So, for example, I have three kids, 22, 21, and 18.

01:26:00 ►

They’ve all had to go through driver’s ed.

01:26:03 ►

They all had to have a certain number of hours that they had to drive with their parents in the car.

01:26:08 ►

They had to take a certain amount of education.

01:26:13 ►

And then they had to actually be supervised by somebody who came in the car with them

01:26:18 ►

to see if they were ready to get their license to drive.

01:26:20 ►

So similarly, as we move towards legalization outside of medical context, outside of

01:26:28 ►

religious contexts, we’ll have, I believe, the opportunity to have people who want to go and get

01:26:35 ►

a psychedelic experience to go to one of these behavioral health centers and have an experience

01:26:41 ►

under supervision. And if they don’t have any kind of a crisis or any problem,

01:26:45 ►

then they get a license to buy it on their own and to do in any circumstance anywhere.

01:26:51 ►

So I think that is a step toward.

01:26:54 ►

So initially it’s only designated patients, then it becomes family members,

01:26:58 ►

then it becomes people who want personal growth in these centers,

01:27:02 ►

and then it becomes people who want licenses to go buy it and do it on their own

01:27:06 ►

at Burning Man or wherever.

01:27:09 ►

So I think that

01:27:10 ►

it’s hard to say, but my guess

01:27:12 ►

is that somewhere like 2024

01:27:14 ►

will have

01:27:16 ►

marijuana legalization on a federal

01:27:18 ►

level. I mean,

01:27:20 ►

nobody can say for sure, but I think something

01:27:22 ►

like 2024.

01:27:24 ►

If we get psychedelics medicalized in 2021, for some conditions, I think by, you know, the rollout, by 10 years after that, we’ll probably have several thousand clinics.

01:27:34 ►

And then we’ll have also experience on a federal level for about a decade or so with marijuana legalization. So I think in 2035, more or less,

01:27:46 ►

we should have a culture that’s ready to end prohibition for psychedelics

01:27:52 ►

and hopefully for all the other drugs as well.

01:27:58 ►

So that actually becomes another business opportunity

01:28:02 ►

because it’s not just patients not just

01:28:05 ►

their families but it could be all sorts of people who want psychedelic

01:28:09 ►

treatments under supervision or psychedelic experience is a better way

01:28:13 ►

to say it yeah you have the statistics on how many people have reached out

01:28:19 ►

18,000 are interested and do you also know how many therapists are interested

01:28:24 ►

in being trained

01:28:25 ►

and the second part of that question is did you say 2018 was probably the next possible time to

01:28:30 ►

start getting trained through maps well the end yeah so i think near the end of 2018 is when we’ll

01:28:36 ►

open up the treatment pro the training therapy program for people training for expanded access

01:28:43 ►

i think we already have about 1600,600 therapists who have contacted us

01:28:47 ►

to be notified when the training program starts.

01:28:51 ►

And we’ve developed a model, which we call our sustainability model,

01:28:57 ►

that calls for us to have 300 therapists trained by 2021.

01:29:03 ►

So we’ve already got about 90 or so.

01:29:07 ►

Well, between now and the end of 2018, we’re not training anymore. But I mean, by 2021,

01:29:12 ►

it becomes a medicine. We want to have 300. And then we want to train at least 300 every year

01:29:18 ►

after that. So that at the end of 10 years, there’s 3,000 people that therapists have been

01:29:24 ►

trained. And hopefully, there’ll be 3,000 or so psychedelic treatment centers.

01:29:29 ►

So we actually probably need to train more than that.

01:29:32 ►

Yeah.

01:29:36 ►

What’s your personal opinion on the CIIS training program, the year-long psychedelic?

01:29:40 ►

Okay.

01:29:41 ►

So for those of you that didn’t hear, the California Institute for Integral Studies has a program that’s a certificate program to train people for psychedelic therapy and research.

01:29:53 ►

It’s not a degree program, but it’s what they call a certificate program because you just pay to get into it.

01:29:59 ►

I think it’s very helpful.

01:30:01 ►

I think it’s very helpful. And what we’ve done is we’ve taken the first week of the MDMA training,

01:30:07 ►

which is this week-long watching videotapes and understanding our treatment manual,

01:30:11 ►

and Michael and Annie Midhover, we’ve made it a part of the CIS training.

01:30:15 ►

So everybody that goes to the CIS certificate program gets Part B, we call it.

01:30:21 ►

Part A is 12 hours of online information that people need to do.

01:30:26 ►

Then they can go into Part A, which we have then integrated into the CIS program.

01:30:32 ►

But that doesn’t mean that everybody that graduates from CIS program will be hired by us to be a therapist.

01:30:38 ►

They have to go through our entire program.

01:30:47 ►

program. And those people that want to go and get degrees in therapy at CIS have the added opportunity of a lot of classes directly related to psychedelic psychotherapy. And what we’re

01:30:52 ►

working on with CIS, I mentioned how we have the ability to give MDMA to therapists as part of

01:30:58 ►

their training. So we’re working on developing a protocol with CIS so that it would be for their students in this program,

01:31:06 ►

and they would receive one dose of MDMA and later a dose of psilocybin too.

01:31:11 ►

So we’re thinking of them as sort of cross-training for psychedelic therapists,

01:31:15 ►

and I think the CIS program is very important for that.

01:31:20 ►

Yes?

01:31:23 ►

Okay, so I have a question about I’ve heard that SSRIs and MDMA don’t mix.

01:31:28 ►

And I was wondering, like I have family with drug-resistant depression.

01:31:32 ►

I was wondering if you have some sort of like protocol.

01:31:35 ►

Like I figure a lot of people with PTSD are also on antidepressants already.

01:31:41 ►

So do you get them off for a little bit or what is it like with that?

01:31:44 ►

Yeah. So what we feel is that the SSRIs mute the effect of MDMA. So we require people to withdraw

01:31:54 ►

not just from SSRIs, but from all psychiatric medications that they’re on. And so it depends

01:32:01 ►

on which one they’re on. So it’s five half-lives of whatever the medicine is plus a week,

01:32:07 ►

and that’s how long the withdrawal process has to be before we let them into the study.

01:32:12 ►

And in a way, this is one of the hardest parts of the study

01:32:15 ►

because these are now people that are taking the drugs that have not really cured their PTSD.

01:32:23 ►

They still have severe to extreme PTSD,

01:32:25 ►

but it’s been helping them somewhat. And they have to stop doing those medicines. So there’s

01:32:30 ►

a period of time where their symptoms are going to come to the surface and they actually may feel

01:32:34 ►

worse. And so what we tell people is this is an important part of the process. You’re unmasking

01:32:40 ►

all of these feelings that you’ve kept muted, but it hasn’t really done you that much good.

01:32:46 ►

And so we have to have close supervision while they’re being monitored by their prescribing psychiatrist

01:32:52 ►

for all these medications if they’re on them, but they’re also in touch with our therapy team.

01:32:57 ►

And surprisingly, though, we find that some people say they feel better once they’re off the drugs than before.

01:33:04 ►

And part of it is that the drugs have side effects, didn’t work that well.

01:33:07 ►

The other part is they’re now hoping, they’ve got their hope again,

01:33:10 ►

that there’s some new treatment.

01:33:12 ►

So we’ve actually had to do a lot of thinking with the FDA

01:33:15 ►

about where is our baseline measure.

01:33:18 ►

Is the baseline measure of their PTSD symptoms when they come to us on their SSRIs,

01:33:23 ►

and this is how they are, this is what

01:33:25 ►

the treatment that they’ve had available has produced in them, or is the baseline measure

01:33:31 ►

after they’ve withdrawn from the drugs and are now ready to start the study. So what the FDA said

01:33:38 ►

they wanted us to do, which is fine with us, is that the baseline measure of PTSD is going to be

01:33:43 ►

after they’ve withdrawn from all their other medications.

01:33:47 ►

So there’s a bunch of people that are not going to be willing to do that.

01:33:50 ►

And we’re finding that.

01:33:51 ►

We have a marijuana PTSD study in Phoenix, Arizona,

01:33:55 ►

funded by $2.1 million from all the pot smokers in Colorado.

01:34:01 ►

So they have a $10 million.

01:34:02 ►

They have made so much money on the taxes.

01:34:04 ►

They put out $10 mi ll i o n . T h ey ha v e ma d eso m u c hm o n eyo n t h e t a x es, an d t h ey p u t o u t$ 10 million for research.

01:34:08 ►

And we’re finding that some of the people that have PTSD that already use marijuana

01:34:12 ►

are reluctant to give it up in order to be in the study

01:34:15 ►

because we need to get them back to kind of a baseline, what is their PTSD,

01:34:20 ►

and then they can enter the study.

01:34:22 ►

So I think it’s going to be a challenge, but many people realize that the sort of holding

01:34:29 ►

pattern that they’re in is not getting them where they want.

01:34:33 ►

And so we provide a lot of support as they taper off their medicines.

01:34:38 ►

Yeah.

01:34:40 ►

Yeah.

01:34:42 ►

The medicine is really abandoned.’s true story even smoking weed is just like it it mutes

01:34:49 ►

it so you don’t have to deal with it so once once everything’s gone that’s what you’re really

01:34:53 ►

dealing with and you can’t know that until you take the rest of it out and it was hard to do

01:34:59 ►

yeah exactly so in a way it really requires courage on a pod of patients to face,

01:35:05 ►

to not only let go of the other drugs that they’re on,

01:35:09 ►

but then be willing to face what comes up.

01:35:11 ►

So we need to honor sort of the courage.

01:35:13 ►

And for those people that aren’t ready to do that,

01:35:15 ►

it’s fine if they want to stay on the medicines,

01:35:18 ►

or it’s fine if they want to use marijuana.

01:35:20 ►

We also require people to stop marijuana to be in the study.

01:35:26 ►

Because, again, we can have

01:35:27 ►

only one intervention at a time.

01:35:31 ►

Yeah.

01:35:32 ►

Yes?

01:35:39 ►

For the therapist team,

01:35:41 ►

is there going to have to be

01:35:42 ►

a psychiatrist on it, or someone to write the prescription?

01:35:48 ►

Or can it be two people who have therapy degrees to

01:35:51 ►

do it? And the second question is, what’s the brand name going to be?

01:35:56 ►

That’s really funny. Well, I’ll do

01:35:59 ►

the harder question first.

01:36:04 ►

The DEA will only give doctors a Schedule I license to work with the Schedule I drug.

01:36:14 ►

So every of our 14 sites have to have a doctor that’s got the DEA Schedule I license.

01:36:20 ►

However, the DEA permits the Schedule I license holder to transfer that authority to administer to other people.

01:36:30 ►

So in our Boulder study, the principal investigator was a psychologist.

01:36:37 ►

The Schedule I license holder was the doctor.

01:36:41 ►

And several of the therapy teams were only a psychologist and a student.

01:36:48 ►

So you do not need to even have a doctor in the room when you’re doing the therapy. But the doctor

01:36:54 ►

has to do the medical evaluations, has to be responsible if there’s a medical crisis.

01:36:59 ►

But the therapy doesn’t have to be only by psychiatrists or only by doctors or even only by licensed psychotherapists or social workers.

01:37:08 ►

We’re having nurses, but we’re also having students that don’t have any licenses at all.

01:37:14 ►

And so this sort of gets back to the clinic model.

01:37:16 ►

You may have one Schedule I license holder that operates the clinic

01:37:20 ►

and then a bunch of therapists that work under their supervision and direction.

01:37:27 ►

And then our goal is to have both the Schedule I license holder, at this point it would be

01:37:32 ►

Schedule II, but for research, Schedule I, and also the people that are in touch with

01:37:38 ►

the patients, all of which would need to be through our training program.

01:37:44 ►

So just to clarify, so you have these teams,

01:37:48 ►

and one member of the team could be an unlicensed person

01:37:52 ►

who just has interest in doing this?

01:37:54 ►

Well, we call that the Rick Doblin loophole

01:37:57 ►

because I want to be a therapist,

01:38:01 ►

and I’m not so sure I want to go through years and years of formal training.

01:38:06 ►

So I’ll need to find a female therapist with a license to be a therapist or even a social worker, and I’ll just need to be a partner.

01:38:16 ►

So, yeah, one person doesn’t need any license at all.

01:38:19 ►

And they can do the MAPS training.

01:38:22 ►

And they can do the MAPS training.

01:38:23 ►

They can be students.

01:38:24 ►

We’ve already trained a bunch of students.

01:38:26 ►

Because, again, it’s really unorthodox to have two therapists.

01:38:30 ►

But when you have an eight-hour session, and I’ll say one thing also,

01:38:35 ►

which is that our goal, our primary strategy has been to maximize therapeutic outcomes.

01:38:43 ►

And this gets back to your question about insurance coverage

01:38:45 ►

and how that’s going to happen.

01:38:47 ►

We’re not looking to figure out what’s the least amount of therapy

01:38:50 ►

that can get somebody without PTSD by the fewest number of sessions.

01:38:56 ►

And that’s really important,

01:38:58 ►

and we have to figure that out for widespread implementation.

01:39:02 ►

But for the approval process,

01:39:04 ►

really we need as

01:39:06 ►

robust of the outcomes as we can get

01:39:08 ►

to get over all the

01:39:09 ►

political concerns about MDMA.

01:39:12 ►

So we are just

01:39:13 ►

insisting on this

01:39:15 ►

two-therapist model.

01:39:18 ►

But once it’s approved,

01:39:19 ►

it might not need to be

01:39:21 ►

two therapists either.

01:39:23 ►

And if it’s just one therapist,

01:39:25 ►

then they would need to have some sort of license as a therapy.

01:39:28 ►

But if you’re part of a two-person team, the second person could be anybody.

01:39:32 ►

And we found that a lot of the therapists really see the value in the two-therapy team.

01:39:38 ►

They don’t often do that.

01:39:39 ►

They don’t do that in our practice.

01:39:40 ►

And there’s a lot of times where the patient would rather talk

01:39:46 ►

to a male or a female depending on the issues so i really think that kind of model really works well

01:39:54 ►

and it creates a an added sense of safety and insights and so and seeing a successful

01:40:01 ►

partnership too is really helpful for a lot of the patients who’ve lost trust, who’ve been traumatized.

01:40:06 ►

So one day I will be able to be a legal psychedelic therapist even without going back to school.

01:40:17 ►

Yeah.

01:40:24 ►

Piggybacking on that Rick

01:40:25 ►

hi how you doing

01:40:26 ►

I don’t know if MAPS or your organization

01:40:29 ►

are taking steps

01:40:30 ►

you’re saying some of your patients prefer

01:40:33 ►

either a male or a female to speak to

01:40:35 ►

but

01:40:36 ►

training therapists of color

01:40:39 ►

as well for people who

01:40:40 ►

you said they might feel safer with certain people

01:40:43 ►

that decide

01:40:44 ►

I don’t know if that’s part of the curriculum as well or part of, like, the process that you all are doing as well.

01:40:51 ►

What part do you mean about being?

01:40:53 ►

Getting, like, people of color, psychedelic therapists as well and dealing with racial trauma and that kind of thing.

01:40:58 ►

Yeah, definitely.

01:40:58 ►

Yeah, yeah.

01:41:01 ►

The University of Connecticut site will likely be people with PTSD from racial trauma.

01:41:07 ►

One of the things that really surprised us and disappointed us was that of the veterans that applied to be in the study,

01:41:15 ►

there’s an awful lot of veterans who are from minority groups.

01:41:20 ►

But we didn’t have a single veteran in our study from a minority group.

01:41:24 ►

but we didn’t have a single veteran in our study from a minority group.

01:41:30 ►

And I just thought automatically, because there’s so many veterans from minority communities, that we’d have a representative sample.

01:41:34 ►

And so once we realized that that didn’t happen,

01:41:37 ►

now we’ve started to figure out that we need to do more active outreach to minority communities.

01:41:43 ►

There’s a lot of distrust of the medical establishment in the African-American community.

01:41:49 ►

They know about the Tuskegee experiments where people had syphilis, but they weren’t treated.

01:41:55 ►

They were just tracked to see what happens with their disorder.

01:41:57 ►

So there’s a lot of distrust.

01:42:00 ►

And so we’re having to do an extra step to try to reach out to African-American therapists and patients.

01:42:08 ►

You know, there’s transgender trauma, so we’re reaching out to those populations.

01:42:12 ►

But I think what surprised me is that we’re offering a very safe setting with very trained therapists,

01:42:21 ►

and yet still no minority people were willing to volunteer for

01:42:25 ►

the study so that that’s a big issue i mean look around here too i mean it’s psychedelic

01:42:31 ►

bernie man is white psychedelic community is mostly white there’s there are other minorities

01:42:36 ►

but it’s not much african americans and so i think there’s a way in which i guess the way i explain

01:42:43 ►

it is there’s a way in which you become defenseless under psychedelics.

01:42:47 ►

You are letting your ego fall apart.

01:42:49 ►

You’re defenseless.

01:42:50 ►

And if you’re feeling that the world itself is prejudiced against you, you’re going to be reluctant, I think, to enter into these defenseless states.

01:43:09 ►

defenseless states. And so that’s for me maybe the best explanation of why people who need help,

01:43:15 ►

who aren’t adequately helped by what’s available, are still not volunteering for our studies. So I’d say that is a particular challenge that we’re going to have to address, and

01:43:18 ►

I don’t think we have successfully addressed it yet.

01:43:21 ►

have successfully addressed it yet.

01:43:33 ►

I’ve seen some research that MDMA could possibly result in cognitive defect side effects.

01:43:36 ►

Can you tell us more about your understanding of that? Yeah.

01:43:48 ►

The research that began in the early 1980s into neurotoxicity of MDMA and proceeded through the 80s and 90s and sort of reached its peak in the 2000s,

01:43:56 ►

the only functional consequence that has been demonstrated in some of these studies of ecstasy users has been somewhat poor neurocognitive

01:44:09 ►

performance, memory tests, things like that, in people that are heavy ecstasy users.

01:44:16 ►

So the question is, does that happen in a therapeutic context?

01:44:21 ►

And also, is that research really rigorously designed enough

01:44:26 ►

to say it happens from MDMA? So first off, we know ecstasy is around half the time has no MDMA

01:44:34 ►

at all anyway. Ecstasy and molly doesn’t mean it’s really MDMA. But to answer your question,

01:44:40 ►

and because I feel it’s essential that MAPS become the expert on the risks

01:44:46 ►

as well as the benefits that we become

01:44:47 ►

trusted authority on the risks

01:44:49 ►

there’s a methodological

01:44:52 ►

challenge in that the studies

01:44:54 ►

of ecstasy users

01:44:55 ►

and then comparing them with controls

01:44:58 ►

first off what did they take

01:45:00 ►

but secondly they’ve taken loads of other

01:45:01 ►

drugs and so how do

01:45:04 ►

you separate it out and also what causes somebody to volunteer for some of these studies so

01:45:11 ►

there was a astrophysicist who was a member of maps he sent me an email and

01:45:16 ►

he said I have the solution to how you design a study to figure out the

01:45:21 ►

neurocognitive consequences of heavy ecstasy use. And we were like, great,

01:45:25 ►

what’s the solution? He said, well, there’s a population of people that I’m aware of that have

01:45:31 ►

done large amounts of MDMA or ecstasy, but they haven’t done marijuana, they haven’t done alcohol,

01:45:38 ►

they haven’t done caffeine, they haven’t done a host of other drugs. So maybe you can guess, these are Mormons. So we call it our

01:45:46 ►

fallen Mormon study for rebellious Mormons. And there was a period of time before the Mormon

01:45:53 ►

church had declared MDMA part of the drugs you shouldn’t do, that there was not even a prohibition

01:45:58 ►

inside Mormonism to use these drugs. So I gave a $15, 000 g r an t . M A PS g a v e$ 15,000 to researchers at Harvard’s McLean

01:46:10 ►

Hospital who have the expertise in neurocognitive consequences of recreational drugs. They’ve done

01:46:16 ►

studies with marijuana, with peyote, with cocaine. And so they went out to Utah and they did a small

01:46:24 ►

pilot study and discovered that this group really existed.

01:46:27 ►

And they used the pilot data and submitted it to the National Institute on Drug Abuse and got a $1.8 million grant.

01:46:34 ►

So this is a NIDA-funded, Harvard-conducted study, catalyzed by MAPS, but then we weren’t in it at all.

01:46:41 ►

And so it’s by Dr. John Halpern, H-A-L-P-E-R-N. And there’s a whole bunch of papers

01:46:46 ►

discussing it in Medline. And so what they found is when you do a rigorous study with people that

01:46:54 ►

don’t have all these other confounds, that they really didn’t find any evidence of significant

01:47:00 ►

neurocognitive consequences. So there’s debates about, you know, critics are saying, oh, they found some little things,

01:47:07 ►

but you’ll see in the scientific literature that it’s very reassuring.

01:47:11 ►

So for what we had to do for FDA, and this gets more to the question of the therapeutic use,

01:47:17 ►

is in two of our different studies so that we would replicate the results,

01:47:21 ►

we did a series of neurocognitive tests before as a baseline

01:47:25 ►

and then after people had had several MDMA sessions.

01:47:29 ►

That was in our Boulder study and in our first study in Charleston.

01:47:33 ►

And we found no evidence of any neurocognitive decline from only a few doses of MDMA,

01:47:39 ►

nor would we anticipate that there would be such a thing.

01:47:42 ►

So I think we have to recognize that just in the same way is that people who take MDMA in a rave setting

01:47:49 ►

or you’re in Burning Man, dance all night and don’t get adequate fluids,

01:47:53 ►

you can have problems in a recreational setting that are not replicated in a clinical setting.

01:47:59 ►

And at the same time, one of the key negotiations with FDA is going to be whether there’s a lifetime limit

01:48:08 ►

that is placed on the number of MDMA sessions we can give people,

01:48:12 ►

sort of relating to cumulative toxicity if that is a concern.

01:48:17 ►

So that negotiation has not yet happened.

01:48:19 ►

The FDA might not even require that.

01:48:22 ►

But it’s our view that, you know, I’ve taken MDMA about 125 times.

01:48:29 ►

That’s not that much when you think I first started in 1982.

01:48:33 ►

But I don’t feel personally damaged by it.

01:48:38 ►

Maybe I wouldn’t notice.

01:48:41 ►

But the evidence of neurocognitive consequences is pretty weak,

01:48:46 ►

and the research is quite confounded by other variables,

01:48:51 ►

and the best study that you’ll see suggests that it’s not likely to be a problem.

01:48:56 ►

But from the FDA’s point of view, in Phase 2, with these two neurocognitive studies,

01:49:03 ►

we don’t even have to address the question anymore.

01:49:06 ►

So in phase three, we are not doing neurocognitive studies before and after three doses of MDMA.

01:49:12 ►

It’s not even a concern. So how many of you have heard the research that was about

01:49:19 ►

2003 came out about MDMA causing Parkinson’s and hurting dopamine.

01:49:27 ►

Yeah, that was from NIDA, NIDA-funded studies that were done at Johns Hopkins with primates,

01:49:35 ►

and they ended up publishing in Science.

01:49:37 ►

And the editor of Science said that taking MDMA was like Russian roulette,

01:49:44 ►

that you would eventually do major damage,

01:49:47 ►

and it was a real risky thing.

01:49:49 ►

And then this article claimed that MDMA hurt dopamine.

01:49:53 ►

It just didn’t make sense to us.

01:49:54 ►

They treated a bunch of primates.

01:49:56 ►

They killed a bunch of them.

01:49:58 ►

We knew from prior studies that primates did not die from MDMA at that dosage.

01:50:03 ►

They didn’t give it orally the way people take it, so we challenged them.

01:50:07 ►

Science was willing to publish a letter to the editor by us challenging those findings.

01:50:13 ►

And so the researchers, unbeknownst to us, tried to replicate their findings

01:50:18 ►

and to replicate them oral administration, and they couldn’t replicate their results.

01:50:24 ►

And they kept doing different things where they would increase the temperature of the animals.

01:50:29 ►

They would increase the crowding of the animals.

01:50:31 ►

They would increase the frequency of the MDMA.

01:50:33 ►

They would increase the doses.

01:50:36 ►

And they absolutely could not replicate this damage to dopamine.

01:50:41 ►

And they were so mystified.

01:50:42 ►

Now, this took them like a year and a half or so and the

01:50:45 ►

whole time they’re still standing by their study mdma is dangerous causes parkinson’s but quietly

01:50:51 ►

unbeknownst to us they were having a failure to replicate and as a desperation move they did an

01:50:59 ►

autopsy in one of the animals and discovered that they had been giving the animal methamphetamine

01:51:03 ►

instead of MDMA.

01:51:06 ►

And then they tracked it back, and they had gotten a bottle of MDMA and a bottle of methamphetamine

01:51:10 ►

shipped to Hopkins on the same day, and they blamed the supplier, Research Triangulants,

01:51:16 ►

for switching the labels on the bottles. The supplier said, absolutely not, they don’t do

01:51:21 ►

that, that’s not what happened. NIDA never did a formal study.

01:51:26 ►

There’s never been a what’s really happened. But that was the high point of the fears,

01:51:33 ►

exaggerated fears about the neurotoxicity of MDMA. And so ever since then, it’s not been much of a

01:51:40 ►

problem. And I think sort of to summarize that you can do too much MDMA. And if you do it

01:51:45 ►

too frequently, due to high doses, the main concern I’ve seen is that people who are looking for MDMA

01:51:53 ►

to enhance their emotions, to feel more deeper, the more you do it, the more frequently you do it,

01:51:58 ►

you end up muting your emotions. And again, it’s this concept of the experience and the integration of the experience.

01:52:07 ►

And so in a psychotherapeutic setting, the experience is only one part. The other part is

01:52:13 ►

what you bring back to make the benefits, to make the experiences long lasting. And we find that in

01:52:20 ►

recreational settings where people aren’t necessarily thinking about that, what matters is

01:52:24 ►

the experience, but not what they learn from it and what they bring back. So they keep trying

01:52:28 ►

to have the experience over and over and over. And eventually they get a tolerance, they need

01:52:32 ►

higher doses. But the beautiful thing about MDMA, unlike drugs that you get addicted to, like

01:52:39 ►

cocaine, like opiates, like amphetamines even, is that with MDMA, once you get a tolerance to it, if you up the dose,

01:52:47 ►

it doesn’t bring back the feeling. You get more of the amphetamine, more of the anxious parts of it.

01:52:53 ►

So the people who are sort of wanting that kind of dependence end up burning out and after a year

01:53:02 ►

or so give it up. So we have people that have been, you know,

01:53:05 ►

dependent on opiate for decades,

01:53:07 ►

dependent on cocaine for long periods of time,

01:53:08 ►

but you rarely have people that are heavy ecstasy users

01:53:13 ►

for more than a year or two

01:53:15 ►

because they develop the tolerance,

01:53:18 ►

they can’t get the feeling back,

01:53:19 ►

and eventually they feel kind of washed out.

01:53:23 ►

So there’s a trap, which is that, you know,

01:53:27 ►

because the risks are exaggerated, the trap is the tendency to say, oh, there are no risks.

01:53:33 ►

So there are risks from MDMA. They do have to be respected. I don’t feel that neurocognitive

01:53:39 ►

consequences are likely, even from extended use of MDMA over long periods of time. But I guess I’ll

01:53:48 ►

leave you with one idea, which is that we think about MDMA as a two-day experience, not a one-day

01:53:55 ►

experience. We do it during the day. The therapy is always during the day. The reason we have the

01:54:00 ►

overnight stays is for people to rest and reflect and have time.

01:54:05 ►

And then the second day, it’s more resting.

01:54:08 ►

They can’t have any appointments, any requirements.

01:54:10 ►

They can’t drive home.

01:54:11 ►

Somebody else has to come drive them home.

01:54:13 ►

And we have additional psychotherapy the next day for integration purposes.

01:54:18 ►

And so in that context, we do not administer 5-HTP or anything. In a lot of recreational contexts, people either preload with serotonin precursors

01:54:28 ►

or they administer them while they’re doing them or they administer them the day after.

01:54:33 ►

We don’t do that.

01:54:34 ►

And what we don’t see is these sort of suicide Tuesdays,

01:54:38 ►

the really low dip in mood after MDMA recreational use that some people report.

01:54:45 ►

A lot of that is people have done it at night.

01:54:48 ►

They haven’t properly slept.

01:54:49 ►

The next day they haven’t properly ate.

01:54:51 ►

The next day they don’t rest.

01:54:53 ►

They go back into doing other things or they go to work.

01:54:56 ►

And the stress of that builds up and makes it a contrast between the normal life

01:55:01 ►

and the feelings that they felt with MDMA.

01:55:06 ►

contrast between the normal life and the feelings that they felt with MDMA. So we actually find that the placebo group has more anxiety and depression after several days after MDMA,

01:55:13 ►

after the experimental sessions, than the group that got the MDMA plus therapy. Because the group

01:55:19 ►

that got the therapy with placebo were encountering their trauma, but without the support that the MDMA gives.

01:55:25 ►

And so they ended up feeling more anxious and depressed than the people that got the MDMA.

01:55:30 ►

So all this is part of, I think, what the FDA has come to appreciate as the safety profile

01:55:36 ►

when used in a clinical setting.

01:55:39 ►

And so this debate about exactly how dangerous it is for excessive use, fortunately for us, is a debate that’s important,

01:55:47 ►

but we don’t have to engage in it.

01:55:49 ►

So we have satisfied the FDA

01:55:52 ►

that the administration of three doses of MMA

01:55:55 ►

in our clinical setting is more than the risks of that,

01:56:00 ►

whatever they are, more than balanced out by the benefits.

01:56:07 ►

Yeah.

01:56:07 ►

Well, thank you very much.

01:56:13 ►

Great.

01:56:16 ►

You’re listening to The Psychedelic Salon, where people are changing their lives one

01:56:21 ►

thought at a time.

01:56:24 ►

Well, this has been kind of a long podcast today,

01:56:28 ►

and so I’ll keep my closing remarks brief. Now, if you’ve been with us here in the salon for a

01:56:33 ►

while, you’ve most likely already heard what I’m going to say about the long-term toxicity effects

01:56:38 ►

of MDMA. First of all, if you haven’t already seen the 30-minute video interview that I’ve posted on the homepage of our psychedelicsalon.com website,

01:56:48 ►

the video that’s titled Confessions of an Ecstasy Advocate,

01:56:52 ►

then, if you’re interested in learning more about the early days of MDMA use on the streets of Dallas,

01:56:59 ►

well, this would be a good place to begin.

01:57:01 ►

In it, I tell about the time that I took a huge amount of MDMA and

01:57:06 ►

what effects that experience had on me. Basically, I completely lost the ability for MDMA to have

01:57:14 ►

any effect on me at all, and that lasted for several years. Eventually, after not taking any

01:57:21 ►

MDMA for three or four years, it once again worked its magic for me,

01:57:26 ►

and from then on I never used it more than three times a year.

01:57:30 ►

The other thing is that until I moved out here to the coast,

01:57:33 ►

I never experienced that Tuesday letdown that Rick mentioned.

01:57:37 ►

I think that he called it Suicide Tuesday.

01:57:40 ►

You see, back in the days when we were first learning

01:57:43 ►

how to best use this important medicine,

01:57:45 ►

we generally took it on a Friday or a Saturday night, and so we had all day Sunday to relax and get back to baseline.

01:57:53 ►

So Rick’s advice about setting aside two full days for an MDMA experience, I think, is very important.

01:58:00 ►

As for permanent toxicity and damage to my brain due to the huge dose that I took at one time,

01:58:06 ►

well, that experience was over 30 years ago, and to the best of my knowledge,

01:58:11 ►

I haven’t suffered any loss of mental capacity during that time.

01:58:15 ►

And I most certainly don’t have any holes in my brain.

01:58:19 ►

The only significant problem that I encountered from that stupid trick of taking a huge dose

01:58:24 ►

was that I lost

01:58:25 ►

the use of this medicine for several years. And on top of that, it was the single most uncomfortable

01:58:32 ►

MDMA experience of my life. So the bottom line is that if you were using this medicine on your own,

01:58:40 ►

you would be well served to follow the recommendations about how much to take

01:58:45 ►

and how to best nurture the experience in ways that has been developed by thousands of psychonauts over many years.

01:58:52 ►

There’s no need to reinvent the wheel here.

01:58:56 ►

At least, that’s my opinion.

01:58:58 ►

And for now, this is Lorenzo signing off from Cyberdelic Space.

01:59:03 ►

Be well, my friends. Thank you.

⚗️ alembic

Explorer

550 - FDA Approved Phase 3 MDMA_PTSD Research

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